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The views expressed by authors, editors, or expert groups do not necessarily represent the decisions or the stated policy of the World Health Organization. Document number: WHO/EURO:2010-7102-46868-68340 Acknowledgments This training package was developed by JSI/Ukraine and WHO Regional Office for Europe, Making Pregnancy Safer Programme with the financial support towards the preparation and production of this document provided by the Government of the Unites States of America and JSI. Authors and contributors: Tengiz Asatiani, Nino Berdzuli, Atrem Chernov, Gianpaolo Chiaffoni, Dmytro Dobrianskyi, Pauline Glatleider, Gianfranco Gori, Daniela Iancu, Tamara Irkina, Dalia Jeckaite, Viacheslav Kabakov, Anna Karpushkina, Ivan Lejnev, Ketevan Nemsadze, Audrius Maciulevicius, Irina Matvienko, Natalia Podolchak, Liubov Pozdniakova, Igor Semenenko, Oleg Shvabski, Gelmius Siupsinskas, Elena Sofronova, Fabio Uxa. Coordinators: Alberta Bacci, WHO, Regional Office for Europe, Helene Lefèvre -Cholay, Oleg Kuzmenko, JSI/Ukraine Contents Module 1C. Safe Motherhood and Effective Perinatal Care: Are Changes Necessary? ..... 1C-1 Module 2C. Introduction to Evidence-Based Medicine ................................ ....................... 2C-1 Module 3C. Counselling Skills in Maternal and Neonatal Care ................................ ........... 3C-1 Module 4C. Assessment of Foetal Well -Being During Pregnancy and Labour . Assessment of Small for Gestational Age (SGA) Foetuse s................................ ................ 4C-1 Module 5C. Management of Normal Labour and Delivery ................................ .................. 5C-1 Module 6C. Initial Rapid Assessment of the Newborn and Principles of Neonatal Care ..... 6C-1 Module 7C. Breastfeeding ................................ ................................ ................................ . 7C-1 Module 8C. Postpartum Care of Mothers and Newborns ................................ ................... 8C-1 Module 9C. Neonatal Resuscitation ................................ ................................ ................... 9C-1 Module 10C. Integration of Prevention of Mother to Child HIV Transmission into Effective Perinatal Care ................................ ................................ ................................ ................. 10C-1 Module 11C. Infections in Pregnancy, Childbirth and Postpartum ................................ .... 11C-1 Module 12C. Preterm Labour ................................ ................................ ........................... 12C-1 Module 13C. Sudden Infant Death Syndrome (SIDS) ................................ ...................... 13C-1 Module 14C. Postpartum Depression, Loss and Tragedies ................................ ............. 14C-1 Module 15C. How to Improve Existing Practices: Strategy of Changes ............................ 15C-1 Module 1ɋ Safe Motherhood and Effective Perinatal Care: Are Changes Necessary? Effective Perinatal Care (EPC) 1C - 2 Module 1C Slide 1ɋ-1 Safe Motherhood and Effec- tive Perinatal Care: Are Changes Nec- essary? The main objective of this module is to discuss the modern approaches to effec- tive perinatal care and the necessity of improving existing routine practices. Slide 1ɋ-2 What Are the Eight Millen- nium Development Goals (MDGs)? In the WHO publication (2004), “World Report on Knowledge for Better Health”, the gap between what we know and what we do in practice was highlighted. In or- der to achieve the health-related Millen- nium Development Goals (MDG’s) by 2015, we need to reduce this gap. One of the ways that we can do this is by taking the information that we have from scien- tific research and applying it to the actions that we take to improve people’s health status and the health care system. Maternal and infant health has been a priority long before the 1990s. Program implementation and activities are based on over a century of experience. However, beginning in 2000 the focus shifted to achieving the MDGs and monitoring each country’s progress in doing so. As a result, mothers and children have increasingly become a target group for interventions and more em- phasis has been placed on improving their health. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-3 Motherhood Is a Positive Experience for the Majority of Women ‘Parenthood brings the strong desire to see your children grow up happily and healthy. This is one of few constant points in life in all parts of the world.’ From the Message of the WHO Director General Dr LEE Jong-wook to World Health Day. Geneva, April 2005 1C - 3 Effective Perinatal Care (EPC) Slide 1ɋ-4 However, in the World To- day… “Children are the future of our society and their mothers are the guardians of that fu- ture. However, approximately 11 million children up to 5 years old will die from causes that can be prevented for the most part. 4 million newborns that will not survive during the first months of their lives are among them. In addition to that, 3, 3 million will be dead born. At the same time, about half million of newborns will die during pregnancy, delivery or shortly after that.” The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-5 Maternal Mortality Ratio (MMR) in the European Region in 2004 1C - 4 Today, approximately 300 million women suffer from short- or long-term conditions associated that arise from complications dur- ing pregnancy or delivery. In addition, every year there are approximately 529,000 ma- ternal deaths, 68,000 of which are due to the unsafe termination of pregnancy. Unfortu- nately, maternal mortality is not limited to lower income countries, whereas, only 1% of neonatal and infant mortality cases are found in rich countries. Progress toward im- proving medical and sanitary care during pregnancy and delivery has been improved in most regions of the world, with the exception of the Sub-Saharan Africa Region. While improvements have occurred, the overall picture still remains. Women and their babies in many countries of the world still lack quality effective perinatal care. The slide shows data for maternal mortality in the European Region. Different colours mean dif- ferent rates in various countries. Health For All, database. WHO EURO, 2005 Slide 1ɋ-6 Maternal Mortality Dynam- ics in the European Region, 1980-2004 The probability of dying from pregnancy- and delivery-related complications is 6-7 times higher for women in the Central Asian Republics than in Western Europe. Health For All, database. WHO EURO, 2005 Module 1C Slide 1ɋ-7 Main Causes of Maternal Mortality Global data about the main causes of ma- ternal mortality in the world is presented on the slide. Note that the total percentage is a little more than 100 due to rounding- up. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-8 It Is Impossible to Accept High Numbers of Maternal Mortality Because… 1C - 5 The WHO annual report for 2005, Every Mother and Child Counts highlights the importance of focusing international ef- forts on improving the lives of women and children. The report contains an expert analysis of the barriers to improving ma- ternal and infant health care. In addition, it proposes a complete set of recommenda- tions on how to overcome these barriers. There are interventions in place in many countries already on how to change the lives of millions of mothers and children and how to prevent the many deaths that occur annu- ally. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-9 Child Mortality in the World Under five mortality decreased during the last part of 20th century: from 146 per 1,000 live births in 1970 to 79 in 2003. Nevertheless, this general trend does not develop smoothly in some parts of the world. If in some WHO regions like Amer- ica, South-East Asia and Europe the pro- gress continued or accelerated, in some regions of Africa, Eastern Mediterranean and in Western part of the Pacific a slow- ing down was observed. The rate of infant mortality among children aged under 5 years rapidly decreases in 93 countries accommodating 40% of the whole world population. Less promising progress is monitored in the next group consisting of 51 countries where 48% world population lives. They can reach MDGs only given that the pace of this pro- gress increases significantly. Even more troubling is the situation in the last group of 43 coun- Effective Perinatal Care (EPC) tries where the rest of 12% of population lives. The infant mortality rate is either high or very high and remains on the same level or even increases. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-10 Neonatal Mortality Dy- namics in the European Region, 1980- 2004 The very recent assessment shows that the mortality indicator among the new- borns is significantly higher than it had been expected and constitutes about 40% of mortality indicator among the children up to 5 years old. Nowadays, neonatal mortality is less than 2% in high income countries. As has been seen, the discrepancy between poor and rich countries still grows. The World Health Report. Make every mother and child count. WHO, 2005 Health For All, database. WHO EURO, 2005 Slide 1ɋ-11 Causes of Neonatal Mor- tality in the World, 2001 This slide presents the data on neonatal mortality in the world, 2001. Joy E Lawn, Simon Cousens, Jelka Zu- pan. Neonatal Survival 1: 4 million neo- natal deaths: When? Where? Why? Lancet, Vol. 365 March 5, 2005 1C - 6 Module 1C Slide 1ɋ-12 It Is Impossible to Accept High Numbers of Neonatal Mortality Because… The WHO Report Health Status in the World, 2005 «Every Mother and Child Counts». Slide 1ɋ-13 “Every mother and child counts!” The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-14 Safe Motherhood Program 1C - 7 The Safe Motherhood Initiative was started in 1987 and is an international program targeting health care workers who deal with women during pregnancy, delivery and post-partum period. This ini- tiative was undertaken in order to stimu- late the efforts and to decrease the ma- ternal mortality by 50% by 2000. The Safe Motherhood program indicators were not met however many lessons were learned. Building on the Safe Mother- hood experience, WHO launched the Making Pregnancy Safer Initiative in 2000. The MPS focus is the health sector. The MPS goal of ensuring a skilled attendant for every mother and baby at birth and immediately after will help achieve will help achieve the MDG #4 and #5. Starrs, A. The safe motherhood agenda: priorities for the next decade. NewYork: Inter-Agency for safe motherhood, Family Care International, 1998. Effective Perinatal Care (EPC) The World Health Report. Make every mother and child count. WHO, 2005 MPS Making a Difference in Countries: Strategic Approach to Improv- ing Maternal and Newborn Survival and Health. WHO, 2006 Slide 1ɋ-15 Skilled Attendant 1C - 8 Skilled care refers to the care provided to a woman and her newborn during preg- nancy, childbirth and immediately after birth by an accredited and competent health care provider who has at her/his disposal the necessary equipment and the support of a functioning health sys- tem, including transport and referral facili- ties for emergency obstetric care. Since skilled care as defined above can be pro- vided by a range of health professionals, whose titles may vary according to spe- cific country contexts, it has been agreed to refer to this health care provider as the “skilled attendant” or, “skilled birth attendant”, so as to avoid confusion over titles. In issuing this statement, WHO, ICM and FIGO are advocating for skilled care during preg- nancy, childbirth and the immediate postnatal period. This statement is especially aimed at countries in which the coverage of skilled attendance at birth is below 85%. The statement de- fines clearly who is a skilled attendant, what skills she/he should have and how she/he should be trained and supported. Making pregnancy safer: the critical role of the skilled attendant. A joint statement by WHO, ICM and FIGO. Making Pregnancy Safer, Depart- ment of Reproductive Health and Research, World Health Organization, Geneva, 2004 The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-16 Skilled Attendant Care “All skilled attendants must have the core midwifery skills. The additional skills re- quired will vary from country to country, and possibly even within a country, to take account of local differences such as urban and rural settings." "Core midwifery skills” have been defined by the International Confederation of Midwives in a document entitled “Essential Competencies for Basic Mid- wifery Practice”, available at http://www.internationalmidwives.org" WHO, 2004 page 3. Module 1C The prototype for a skilled attendant is the licensed midwife. Less cost-effective options include nurse-midwives and doctors, assuming they have been specifically prepared to do this kind of work (most are not – or not sufficiently). Gynecologists-obstetricians – of whom there is a large deficit in stagnating and reversal countries – are, as a rule, perfectly able to provide first-level care, although they are less cost - effective and more appropriate for back-up referral care. There is no evidence that lower level staff or non-professionals can deal with the complex deci- sion-making required when complications occur at birth. Providing close-to-client first-level maternal and newborn care is not just a matter of “carrying out normal deliveries”. Such care has three functions. The first is to make sure that the birth takes place in the best of circumstances, by building a personal relationship between the preg- nant woman and the professional. The second function is to resolve complications as they arise, making sure that they do not degenerate into life-threatening emergencies. The third is to re- spond to life-threatening emergencies when they do occur, either directly or by calling on refer- ral-level care that has to be available as a back-up. Making pregnancy safer: the critical role of the skilled attendant. A joint statement by WHO, ICM and FIGO. Making Pregnancy Safer, Depart- ment of Reproductive Health and Research, World Health Organization, Geneva, 2004 The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-17 Main Objectives Perinatal Care Improvement The World Health Report (2005) declares that maternal, neonatal and infant health should possess a central place in ensur- ing that the right to health is protected. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-18 Making Pregnancy Safer Fundamentals The basic fundamentals and principles of effective perinatal interventions were de- veloped by a group of WHO experts of the European Region during PEPC/MPS Task Force meetings in Venice (1998), Verona (2003) and MPS Experts Meeting in Catania, Italy (2007). These principles received a wide support, dissemination and implementation in all counties of the region afterwards. Workshop on Perinatal Care. Report on a WHO Expert Meeting, WHO EURO, Ven- ice, Italy. 16–18 April 1998 1C - 9 Effective Perinatal Care (EPC) 3rd Task Force. Making Pregnancy Safer/Promoting Effective Perinatal Care: From evidence to practice. WHO EURO, Verona, Italy, 22 – 24 October 2003 Making Pregnancy Safer Experts Meeting, WHO EURO, Catania, Italy, 2007 Slide 1ɋ-19 Making Pregnancy Safer Principles Workshop on Perinatal Care. Report on a WHO Expert Meeting, WHO EURO, Ven- ice, Italy. 16–18 April 1998 3rd Task Force. Making Pregnancy Safer/Promoting Effective Perinatal Care: From evidence to practice. WHO EURO, Verona, Italy, 22 – 24 October 2003 Making Pregnancy Safer Experts Meet- ing, WHO EURO, Catania, Italy, 2007 Slide 1ɋ-20 Difficulties and Problems that Exist in Some European Region Countries (1) 1C - 10 WHO Europe, together with WHO Amer- ica organized a conference in the city of Fortaleza (Brazil, April 22-26, 1985) where more than 60 experts (obstetri- cians, paediatricians, health care lead- ers, economists, psychologists and soci- ologists) participated. The participants of this conference made several conclu- sions that are based on the fundamental principle of effective perinatal care: the woman’s central role in making all deci- sions related to safe pregnancy and safe delivery. The main problems that exist for the majority of countries in the European region were formulated there. Joint Interregional Conference on Appropriate Technology for Birth Fortaleza, Brazil, 22 - 26 April . WHO EURO, PAHO, 1985. Module 1C Slide 1ɋ-21 Difficulties and Problems that Exist in Some European Region Countries (2) Based on the recommendations made during the conference in Brazil, WHO experts from the European Region ana- lyzed the existing difficulties and chal- lenges in the provision of effective peri- natal care in some countries in Europe. Joint Interregional Conference on Ap- propriate Technology for Birth Fortaleza, Brazil, 22 - 26 April . WHO EURO, PAHO, 1985. Slide 1ɋ-22 Criteria for the Best Model of Healthcare Safe Motherhood implies not only the prevention of morbidity and mortality but also the provision of quality maternal and infant care. The notion of care includes physical, mental and social well-being of the woman before, during and after childbirth, and should ensure the birth of a healthy baby and healthy childhood. This approach corresponds with the WHO Constitution (1948) that defines ‘health as a complete state of physical, mental and social well-being and not only the absence of the disease.’ Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO Geneva, 1996. The world health report. Health systems: improving performance. Ge- neva, WHO, 2000. Slide 1ɋ-23 Steps in Medical Care – Regionalization Regionalization is the rational distribution of medical services on the whole territory where services and facilities of all levels (primary, secondary, and tertiary) are focused in the places easily accessible for the population and provide cost- effective medical care. This system turned out to be very effective, especially in perinatology. A regional system im- plies a big amount of medical facilities that provide care for the mothers and newborns on the (primary) peripheric level (including maternities and rural 1C - 11 Effective Perinatal Care (EPC) hospitals), several district hospitals of the secondary level and just few hospitals of the tertiary level such as University hospitals with the intensive care units. An integrated network between primary, secondary and tertiary levels is necessary to provide safe and effective medical care on each level as well as during transportation for hospitalization or transfer from one level to another. Therefore, a medical care system with a good communica- tion system, effective management in terms of hospitalization, transportation (esp. vehicles) available and a general system of data collection is needed. Moreover, for planning services, it is important to monitor the system and provide post-graduate education. It is also important to make clinical protocols available for effective work and to ensure mutual information exchange in regard to the important clinical and management information. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002. “Within the United Kingdom, as well as in many other European countries, it is now accepted that neonatal intensive care should no longer be left to local initiatives, but has to be commis- sioned on a regional basis. Regionalization of high risk perinatal health care by establishing and commissioning managed clinical networks aims to maintain equality of access whilst maximizing the level of evidence based care and outcome, working in partnership with agreed patterns of referral and shared protocols. The aim is a flexible organization that can respond well to a changing environment. As a result, a stand alone, reliable and effective neonatal transport team with strong clinical and managerial leadership is considered as a crucial, although not exclusive, component to the success of a network.” Contemporary neonatal transport: problems and solutions. L Cornette, Arch. Dis. Child. Fetal Neonatal Ed. 2004;89;212-214 Slide 1ɋ-24 Family Satisfaction Is a Reliable Indicator of Healthcare Qual- ity and Overall Quality of the Health- care System It is not unusual that woman voices are often not heard in the health care sys- tem. If we do not pay attention to the wishes and needs of the main clients (users of services) of the system we will not be able to improve access to the available services and increase the indi- cators elaborated in the recommenda- tions. The World Health Report. Make every mother and child count. WHO, 2005 1C - 12 Module 1C Slide 1ɋ-25 Women’s Expressions Oakley, et al. (1992) reviewed the sources where the opinions and experi- ences of women seeking antenatal care in the UK were presented, and summa- rized them in the research. The following topics were distinguished as key: x Duration of care x Actions to solve the social prob- lems of women and their respon- sibilities x The importance of the ability to listen to the woman and to pro- vide her with the necessary in- formation. Oakley A. et al. Measuring the effectiveness of psychosocial interven- tions in pregnancy. Intl J Technol Asses Health Care, 1992, 8 (1): 129- 38 1C - 13 Slide 1ɋ-26 What Do Women Say? Taylor and Dower (1997) conducted fo- cus group discussions (FGDs) with women in the United States of America regarding their needs in health care and the existing system of care that they re- ceived. Women who participated in the study indicated several issues in the health care systems that did not meet their needs, including the following: x Specialized treatment of one or- gan/system without comprehen- sive attention to the whole body x Disease treatment and medical therapy without attention to main- taining overall health and general well-being x Lack of consideration of physical health in the context of mental health, environment and life circumstances x Superior attitude of the health care workers, lack of politeness, respect, compassion and care. Taylor, Diana, C. Dower, Creation of medical care system oriented to the needs of women: experience, opinions, needs. Health Care for Women International. l, 1997,18:407-422 Effective Perinatal Care (EPC) Slide 1ɋ-27 Opinions of Moldavian Women Women from Moldova expressed similar wishes in regard to the organization of the health care system there. Mikhailov and Bogush, representatives of Opinii Flux, a Moldovian research group that studies market opportunities, conducted focus group discussions (FGDs) in four Moldovian hospitals. They investigated women’s perceptions of pre- and post- partum care. The majority of the women expressed the following opinions: x Unsatisfactory quality of antenatal care due to the fact that health care workers had a very formal attitude x Limited information regarding delivery, breastfeeding, and family planning. The following recommendations were made on how to re-organize pre- and post-partum care: x Maintain continuity of care x Facilitate the dissemination of information regarding contraception, STIs, care during pregnancy, personal hygiene, newborn care, development and education of children. Antenatal Care. Training Course, Maternal Health Project. Russia. JSI/USAID, 2004. Slide 1ɋ-28 Women’s Experiences of Birth: What Women Remember as Unpleasant Professor Beverley Chalmers (UK) ran several research studies on the quality of perinatal care in Russian Federation (St. Petersburg.) The results of these studies were published in the journal ”Birth”. Some of these results are demonstrated on this slide. Beverley Chalmers et al., Women's Ex- periences of Birth in St. Petersburg, Russian Federation, Following a Mater- nal and Child Health Intervention Pro- gram, Birth, 1998, 25 (2), 107–116. 1C - 14 Module 1C Slide 1ɋ-29 Worldwide women want the same things to be taken into ac- count when providing them with qual- ity perinatal care 1C - 15 The modern approach to perinatology implies that care that takes into consid- eration informational, social, and emo- tional needs of all pregnant women and their families during pregnancy, delivery, and in the post-partum period as well as their needs for comfort and support. The midwifery-led model of care is based on the belief that childbirth is a normal and enjoyable life event. Sometimes this model is also called, “family-oriented de- livery.” The woman has to participate in the decision making in regard to the care given. For example, she can participate by measuring her own weight and by familiarizing herself with the fundal height measurements. It is important to maintain the continuity of care by the same health care worker in antenatal care. An ongoing relationship between the woman and the midwife or the medical doctor can facilitate the development of mutual trust and respect. The midwifery-led/first-level care is char- acterized by listening to the woman and her concerns, giving her reliable information, and sup- porting the choices she makes, all based on her individual needs. Slide 1ɋ-30 However, Very Often… “…It is not scientifically proven that a hos- pital is a safer place for the women with uncomplicated pregnancy to deliver than her own home…“ Peter F. Schlenzka, "Safety of Alternative Approaches to Childbirth," Stanford Uni- versity, March 1999 Effective Perinatal Care (EPC) Slide 1ɋ-31 Two Models of Perinatal Care Two most commonly used models of perinatal care are presented on this slide. Essential Antenatal, Perinatal and Post- partum Care. WHO EURO, Copenhagen, 2002. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-32 Appropriate Technologies 1C - 16 Adequate or relevant technology is de- fined as methods, procedures, and equipment applied from the scientific point of view, adjusted to the local condi- tions, and appropriate for the people who apply them and in regard to the people who are the target group. They are also considered adequate when the popula- tion can use and maintain them based on the existing resources. Beverley Chalmers, Viviana Mangiaterra, Richard Porter. WHO Principles of Peri- natal Care: The Essential Antenatal, Perinatal, and Postpartum Care Course. Birth 28 (3), (2001) 202–207. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002. Slide 1ɋ-33 Appropriate Technologies in Perinatal Care This slide lists scientifically-based appro- priate technologies in perinatal care. Essential Antenatal, Perinatal and Post- partum Care. WHO EURO, Copenhagen, 2002. Module 1C Slide 1ɋ-34 Safe Motherhood Princi- ples 1C - 17 Ensuring antenatal care for each preg- nant woman is the primary responsibility of the family where this woman resides. The woman needs support of her family and community during pregnancy, deliv- ery, the post-partum period as well as during lactation especially when she has complications. To provide this care, the family needs information, skills and moti- vation to make an impact in maintaining this new practice. This approach will re- quire social and financial support on be- half of the community. Moreover, it will require support from the health care system though adequate, sensitive, and friendly services that provide a comprehensive set of services in maternal and perinatal care, taking into consid- eration the physical, emotional, and psychosocial needs of women and newborns. Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO Geneva, 1996. Slide 1ɋ-35 Principles of Effective Perinatal Care Is there anything unsatisfactory about maternal and infant health care as we currently practice it? How does our work compare to that of other medical special- ties? The challenge in our field is that we focus on pregnancy, which is not a dis- ease, whereas other specialties focus on diseases. And, and in most cases preg- nancies do not need much medical inter- vention. Therefore, the difference in care that is needed for someone with cancer is very different than what is needed for someone who is pregnant. This is why it is not clear why pregnancy was to be treated in pure accordance with medical rules for so long during the last century. We now see that this approach has led to a system heavily focused on medicalized care to assist in the majority of cases. This system can and often does act against the interests of mothers and newborns. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002. Effective Perinatal Care (EPC) Slide 1ɋ-36 Appropriate Technologies in Perinatal Care The reduction of use of medications, di- agnostic techniques, and interventions in pregnancy should be based on the prin- ciple that pregnancy is a physiological state and not a disease. In other words, birth should not be considered a problem and newborns should not be considered patients. Nevertheless, such an ap- proach implies still implies that we pro- vide adequate care during pregnancy, delivery and in the post-partum period at all levels. Murray W. Enkin et al. A guide to effective care in pregnancy and child- birth. Oxford University Press, 3rd Edition, 2000. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002. Slide 1ɋ-37 Is It Necessary to Spend Limited Resources for…? It is not rational to spend limited re- sources on high cost technologies with little proven effectiveness or need in the health care system which can prevent the use of effective technologies be- cause resources are limited. Slide 1ɋ-38 Correlation between Skilled Attendant Care and Neonatal Mortality Rate Childbirth can be a moment of high risk, although more than half of maternal mortal- ity cases happen in the post-partum period. There are effective measures to prevent many deaths and disability cases in the post-partum period. In order to reduce ma- ternal and neonatal mortality high quality professional care is needed during labour and in the post-partum period. Lack of ac- cess to this professional care is also of great concern and without it can quickly lead to an increase in deaths. 1C - 18 Module 1C High quality professional antenatal and post-partum care is needed for all mothers and infants and not only to those who are considered to be at risk of complications. This care should be lo- cated close to where people live and should be adjusted to the local conditions, culture, and traditions surrounding childbirth. At the same time, care should be safe and include highly quali- fied professionals who can make necessary and quick interventions in the event of complica- tions. This first-level care can be provided skilled attendants in midwifery-led birth centres and in maternities by a certified midwife or a competent medical doctor. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-39 Targeted Interventions for Mothers and Children Midwives and other skilled providers can predict, avoid or solve many unexpected and sometimes dangerous problems that can happen during delivery, thus reducing the level of maternal mortality to the very low numbers. Nevertheless, health care workers also need support that can be provided only in a hospital when they face the limits of their professional training and the available equipment is not enough to solve complicated cases of delivering women. All women need midwifery-led first-level care whereas additional support is needed only in the minority of cases. At the same time, the two types of care should work together and simultaneously to provide effec- tive comprehensive service. In many countries post-partum care is provided even more seldom than care during delivery. This is an extremely important field where many opportunities exist to improve the situation. The World Health Report. Make every mother and child count. WHO, 2005 Slide 1ɋ-40 Importance of Interna- tional Collaboration 1C - 19 One of the key points in the development of modern obstetrics is to stimulate in- ternational collaboration. Taylor, Diana, C. Dower, Creation of medical care system oriented to the needs of women: experience, opinions, needs. Health Care for Women Interna- tional. l, 1997,18:407-422 Oakley A. et al. Measuring the effective- ness of psychosocial interventions in pregnancy. Intl J Technol Asses Health Care, 1992, 8 (1): 129-38 Effective Perinatal Care (EPC) Slide 1ɋ-41 Effective Technologies Do Exist, but Their Implementation De- pends on Us An example of the lengthy implementation of an effective technology. Mark R. Anderson. A Short History of Scurvy. 2000 Slide 1ɋ-42 Four Key Questions to Ask Yourself about What You Do on the Job 1C - 20 It is clear now that historically much of what had had been done in medical practice did not have a proven measure of effectiveness. However, today, many medical interventions are carefully ana- lyzed. As a result, it becomes clear that much of what was done was a waste of resources on the one hand, and may have in fact been harmful on the other hand. We raise the question of the necessity of evidence-based medicine and we hope health care workers will ask themselves the four key questions to access their actions. Module 2ɋ Introduction to Evidence-Based Medicine Effective Perinatal Care (EPC) 2C - 2 Module 2C Slide 2ɋ-1 Introduction to Evidence- Based Medicine At the end of this module the participants will: x Have a better understanding of the principles of evidence-based medicine x Learn the methods and approaches of evidence-based medicine x Be able to critically assess the interventions they perform in their daily practice in terms of evidenced-based medicine x Become familiar with available evidenced-based data and use. Slide 2ɋ-2 How Are Decisions Made? Slide 2ɋ-3 Is What We Are Doing Correct? The quotation of Dave Sackett, professor of clinical epidemiology and head of the Centre for Evidence Based Medicine in Oxford, the father of evidence based medicine. Richard Smith. Thoughts for new medical students at a new medical school. BMJ. 2003;327;1430-1433 doi:10.1136/bmj.327.7429.1430 2C - 3 Effective Perinatal Care (EPC) Slide 2ɋ-4 Is What We Are Doing Correct? The quotation of Peter Morgan, Scientific Editor of Canadian Medical Association. A Healthy Heritage. Collecting for the Future of Medical History. Proceedings of a conference held at the Wellcome Trust 25–26 February 1999 The Wellcome Trust. London, UK, 1999. Slide 2ɋ-5 Traditional Wisdom “Dr. Kerr White, the former deputy director for health services at New York’s Rockefeller Foundation, isn’t likely to forget that talk he gave in 1976 on evidence-based medicine. He was telling his audience that only 15 to 20 percent of doctors’ interventions had been proven to do more good than harm, when a voice called out in mid-sentence: “Kerr, you’re a damned liar. You know perfectly well that it isn’t more than 10 percent!” Unmistakably, the voice belonged to Dr. Archie Cochrane — noted British epidemiologist, pioneer of evidence-based medicine, and a man never afraid to speak his mind. It was Archie who famously observed in 1979 that the medical profession lacked a critical summary of randomized controlled trials (RCT)s. His words led to the formation of the first Cochrane Centre, launched 10 years ago in Oxford, England. Today, there are 15 Cochrane Centres around the world which facilitate the work of an international group of researchers inspired by Archie’s vision”. Kristine Culp. Archie Cochrane. Scottish Medical Journal, August 2002 2C - 4 Module 2C Slide 2ɋ-6 Regularly Review Medical Literature Clinicians need new clinically significant evidence at the rate of two per every three patients examined, affecting eight clinical decisions per day. The number of medical journals has doubled since the 1970s and the amount of information grows daily. About 6000 new scientific articles published in the world every year. Doctors must, therefore, read up to 20 articles per day to keep up with the new evidence in their field. Note, though, that almost 95% of all medical journal articles do not meet the minimum standards of quality. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. 3rd Edition. Oxford University Press, 2000 Slide 2ɋ-7 Basic Information "Evidence based clinical practice is an approach to decision making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best". Muir Gray JA. Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone, 1997 Health professionals need different types of information to answer the questions constantly emerging in their daily practice. For example, students or interns often need basic information explaining the reasons and pathogenesis of a disease, physiological abnormalities, etc. Basic information is relatively stable and relates to anatomy, physiology, pathogenesis, aetiology. It may be found in textbooks, manuals, and other common sources. More often, practicing doctors need answers to questions related immediately to patient care and treatment. Muir Gray JA. Evidence-based healthcare: how to make health policy and management decisions. London: Churchill Livingstone, 1997 2C - 5 Effective Perinatal Care (EPC) Slide 2ɋ-8 Information on Patient Care "Evidence based medicine requires you not only to read the right papers at the right time, but also to alter your behaviour (and, what is often more difficult, the behaviour of other people) in light of what you have found". Greenhalgh, T. How to read a paper: the basics of evidence based medicine, London: BMJ, 1997, p. 2. "Evidence-based medicine involves evaluating rigorously the effectiveness of healthcare interventions, disseminating the results of evaluation and using those findings to influence clinical practice. It can be a complex task, in which the production of evidence, its dissemination to the right audiences, and the implementation of change can all present problems". Appleby J, Walshe K and Ham C. Acting on the Evidence. Birmingham: NAHAT, Research Paper No. 17, 1995 Another type of information relates directly to patient care - methods of diagnosis, treatment, and prognosis. Evidence-based medicine deals primarily with these issues. The objectives of this module relate to the approaches and information regarding patient care (diagnosis, treatment, and prognosis). Greenhalgh, T. How to read a paper: the basics of evidence based medicine, London: BMJ, 1997, p. 2. Appleby J, Walshe K and Ham C. Acting on the Evidence. Birmingham: NAHAT, Research Paper No. 17, 1995 Slide 2ɋ-9 Is What We Are Doing Correct? Much of what we do is not based on good quality medical evidence. 2C - 6 Module 2C Slide 2ɋ-10 Quality Medical Evidence High oxygen concentration has been used regularly for neonatal resuscitation in intensive care units. Although the intended outcome (survival) improved, over 10,000 newborns became blind as a result. This catastrophe could have been avoided if the effectiveness and appropriateness of new technologies were proven by quality medical evidence before extensive use. Uncontrolled oxygen therapy: x 1900 – Budin recommends the use of oxygen in preterm newborns with the cyanosis attacks x 1923 – Bakwin notes that administration of oxygen not only reduces cyanosis, but also prevents its further episodes x 1940 – retrolental fibroplasia or retinopathy was described x 1942 – Wilson reports that breathing of 70% oxygen normalizes breathing in preterm neonates x 1950 – retrolental fibroplasia or retinopathy was recognized as the main cause of infant blindness x 1951 – the connection between uncontrolled oxygen therapy and infant blindness was suspected x 1953 – about 10,000 of cases of blindness due to retrolental fibroplasia were registered worldwide and, finally, a randomized clinical trial (RCT) on liberal versus limited use of oxygen in newborns with birth weight less than 1,500 g was initiated by 8 American hospitals. Silverman WA. Retrolental fibroplasia: a modern parable. Monographs in Neonatology. New York:Grune & Stratton, 1980, Chapter 7. Campbell K. Intensive oxygen therapy as a possible cause of. retrolental fibroplasia: a clinical approach. Med J Australia, 1951, 2, 48–50. Crosse V.M. & Evans P.J. Prevention of retrolental fibroplasia. Arch. Ophthal., July 1952, 48, 83-87. Slide 2C-11 Is What We Are Doing Correct? "Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannised by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients". Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. 2C - 7 Effective Perinatal Care (EPC) Clinical experience often helps the doctor to select the most appropriate tactics of treatment. However, in many situations the methods of treatment based solely on experience and not tested in clinical trials, are not only ineffective but may even harm the patients. Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. Slide 2C-12 Individual Clinical Experience Is Good, but It Isn’t Enough (1) The following are some examples of where clinical experience was not enough: x Routine tracheal intubation in newborn with oesophageal atresia. This recommendation was developed by Ukrainian surgeons. Upon transferring from the maternity to the surgery department, neonates with oesophageal atresia developed pneumonia. The surgeons decided to intubate every neonate with oesophageal atresia, irrespective of their clinical condition (presence of breathing difficulties). This decision was approved by a decree at the national level. Yet a simple and effective alternative exists: intubating only in the event of severe respiratory distress. x By treating threatened miscarriages, pregnancy is maintained in 85-90% of cases. It has been widely accepted that treatment was effective, and doctors did not doubt its necessity. But have doctors tried not treating threatened miscarriage? What percentage of pregnancies will not abort if no treatment is prescribed? Only a clinical experiment, however, can answer this question and determine the effectiveness of treatment – by comparing the rate of miscarriage in the group of women receiving the treatment with the group of no treatment. If in the untreated group the rate of maintained pregnancies is also 80-95%, is it justifiable to prescribe medicine when foetal tissues and organs are being developed? Slide 2ɋ-13 Individual Clinical Experience Is Good, but It Isn’t Enough (2) Professional opinion consists of knowledge and skills, clinical experience, intuition. This is a set of qualities which in combination make up to the so-called clinical experience (internal evidence). It is necessary for correct application of the evidence gained by the others (external evidence). If the external evidence is not implemented, the clinical practice becomes obsolete and the use of ineffective, often harmful treatments may continue further on. 2C - 8 Module 2C Slide 2ɋ-14 Is What We Are Doing Correct? Many painful, unpleasant, humiliating technologies have been used for long time, despite no proven effectiveness. Slide 2ɋ-15 Is What We Are Doing Correct? There are a number of common technologies or practices can be unpleasant for patients and have no proven effectiveness. They include: x Prohibition / limitation of visits to mothers in hospital x Rakhmanov birthing bed x Restriction of food and liquid consumption in labour x Routine enema before delivery x Routine perineal shaving x Routine catheterization of the urinary bladder after birth x Use of ice pack x Routine vaginal examination x Antiseptic treatment of the vagina x Separation of mother and baby immediately after birth. Slide 2ɋ-16 Showing the Effectiveness and Safety of Interventions (1) To prove the effectiveness and safety of a treatment or preventive measure a clinical trail should be performed. In a clinical trial, one group of eligible study participants receives the new, experimental treatment while the other group (control group) receives the old, traditional treatment or a placebo. The new method is considered effective if it results in a lower statistically significant rate of undesirable outcomes (mortality, morbidity). Clinical trials can differ in reliability of results, depending on the 2C - 9 Effective Perinatal Care (EPC) design or methodology of the study. Evidence obtained in RCT is the most reliable and clinically valuable. Why do you think the results of RCT are most reliable? Slide 2ɋ-17 Showing the Effectiveness and Safety of Interventions (2) Imagine that a young scientist organizes a clinical trial of a new drug to reduce arterial blood pressure. The scientist forms two groups of patients: one group (Ⱥ) receives the new treatment; the other group (B) receives the traditional treatment. To determine the effectiveness of the new treatment, the scientist plans a study of the two groups for three years to compare mortality and severe morbidity between the two. Slide 2ɋ-18 Showing the Effectiveness and Safety of Interventions (3) The scientist analyzes the data after three years and finds that in Group A, mortality and morbidity (myocardial infarction and stroke rates) were half that of Group B. The scientist concludes that the new treatment is highly effective and shows the results to an expert in the field. The expert reviews the results of the trial and asks the scientist: Did the decrease in morbidity and mortality in Group A result from the new treatment or from the fact that the average patient age of Group A is significantly lower than that of Group B? Could the age difference affect the outcome? Slide 2ɋ-19 Showing the Effectiveness and Safety of Interventions (4) The scientist performs another clinical trial of the new drug to treat hypertension. This time the scientist defines two groups of patients and ensures that all patients are of the same age. Once again, one group receives the new treatment and another group receives the traditional treatment. After three more years, morbidity and mortality, in Group A (new treatment) are half that of Group B (traditional 2C - 10 Module 2C treatment). However, the expert is still not sure whether it was the treatment that affected morbidity and mortality in Group A since the average body weight of Group A is significantly lower than that of Group B and weight is related to cardiovascular disease. To prove that it was the new treatment rather than a difference in age or weight (or some other factor that might independently affect the outcomes of interest), upon enrolment in the study the participants in both groups must be similar in all ways except the type of treatment received. Slide 2ɋ-20 Randomized Controlled Trials Randomization is a procedure of randomly assigning patients to the intervention and control groups. By doing this, one can assure that there are no significant differences between the two groups and ensure that changes in outcomes cannot be attributed to anything other than the treatment. There are a number of other characteristics of good quality clinical trials such as: o the majority of patients involved must be followed for a sufficient period of time to reveal the outcomes (completeness of the trial) o the patients must be analyzed in the groups where they were placed as a result of randomization (regardless if they received experimental treatment or not) o the groups must be homogenous at the beginning of the trial (if they are not, randomization was probably not well done) o the best trial should be blind both for the patients and for the researchers (double-blind). SUNY Downstate Evidence Based Medicine Course. State University of New York, USA, 2002 Slide 2ɋ-21 “Double-Blind” Studies One of the characteristics of a good quality clinical trial is that it is “double- blind”. A “double-blind” study is when neither the patient nor the doctor knows to which group the patient has been assigned. In trials studying a type of drug in tablet form, it is relatively easy to ensure that the study is “double-blind”. One tablet is the test drug (experimental group) and the other is the placebo (control group). Both tablets are of the same size, shape and colour so that neither the patient nor the doctor knows which is the test drug or the placebo. . Researchers must be aware, however, of the “placebo effect.” The placebo effect can have the following manifestations: 2C - 11 Effective Perinatal Care (EPC) x The patient believes that he receives a new effective treatment, so he is more optimistic and feels better. This results in an over-estimate of positive outcomes. x The doctor believes that her patient has received a new effective treatment and, thus, is optimistic about the outcomes. She focuses on more positive signs, encouraging the patient, resulting in an over-estimate of positive outcomes. SUNY Downstate Evidence Based Medicine Course. State University of New York, USA, 2002 Slide 2ɋ-22 RCTs in Midwifery/Obstetrics Midwifery and obstetrical care have been influenced by a number of RCT including: A review of studies on continuous support for women during labour and birth shows beneficial effects: more likely to have a vaginal birth, less likely to have intrapartum analgesia or to report dissatisfaction with their childbirth experience. Several benefits for upright position in second stage including shorter second stage, less assisted delivery, reduced episiotomy, reduced reports of pain, less abnormal fetal heart rate. The Bristol trial is one of many studies proving the effectiveness of active management of the 3rd stage of labour for reducing the risk of postpartum haemorrhage A study on eclampsia proved that magnesium sulphate is the most effective drug to treat fits of eclampsia. It ended the long argument between those supporting the use of magnesium sulphate and those who thought that Diazepam was the best drug for eclampsia. The MAGPIE RCT involved over 10,000 women with pre-eclampsia. The trial proved that magnesium sulphate is also effective for severe pre-eclampsia. Other RCT have shown that corticosteroids significantly reduced perinatal mortality and morbidity in women with threatened preterm delivery. Slide 2ɋ-23 Trials Can Deny Rather than Support Effectiveness There are also examples of RCTs that have found that the proposed or tested treatment is not effective. Some of these procedures have been performed during labour for many years. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000 2C - 12 Module 2C Slide 2ɋ-24 Neonatal Care Trials The use of 100% oxygen for the initial stages of neonatal resuscitation is a standard procedure. Some clinics, however, use oxygen of less than 100% concentration to start resuscitation. Evidence shows that this approach is also effective. If oxygen support is unavailable, the newborn should be ventilated with room air. Saugstad OD et al. Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study. Pediatrics, 1998; 102. Objective of this RCT was to compare the incidence of omphalitis among three groups, each using a different type of newborn cord care: topical antiseptic, dry care, and topical application of antibiotic. Conclusion: it is no difference between routine antibiotic and antiseptic application and dry open cord care. Zupan J et al. Topical umbilical cord care at birth. The Cochrane Database of Systematic Reviews, 2004, Issue 3. Newborns with meconium-stained amniotic fluid are routinely intubated and aspirated. Evidence, however, suggests that routine intubation of an active newborn increases the rate of meconium aspiration syndrome, laryngospasm and pneumothorax. Intubation may be both difficult and unnecessary. As a result of such trials, routine intubation was removed from the program of neonatal resuscitation. “Until further evidence is available routine intubation of vigorous term meconium stained babies to aspirate the lungs should be abandoned. Suctioning of the oro-pharynx may be beneficial but endotracheal intubation should be reserved for depressed or non vigorous infants or those who develop signs of respiratory distress following initial assessment.” Halliday HL, Sweet D. Endotracheal intubation at birth for preventing morbidity and mortality in vigorous, meconium-stained infants born at term. The Cochrane Database of Systematic Reviews, 2001, Issue1. Slide 2ɋ-25 Reliability of Evidence Considering the likelihood of errors and wrong conclusions, evidence has been ranked in terms of reliability as follows: o Level A (highest level of reliability): recommendations based on the results of systematic reviews of RCT provide the most reliable evidence (Level 1a) while recommendations based on the results of a single RCT are a notch lower (Level 1b). o Level B: recommendations based on the results of clinical trials but which are of lower quality than RCTs. This 2C - 13 Effective Perinatal Care (EPC) includes cohort studies (Level 2a and 2b) and case-control studies (Level 3a and 3b). o Level C: recommendations based on the results of a series of cases and poor quality cohort and case-control studies (without control group). o Level D: recommendations based on expert opinions without explicit critical appraisal or recommendations based on physiology. Guyatt GH et al. Users' guides to the medical literature. IX. A method for grading health care recommendations. Evidence- Based Medicine Working Group, JAMA, 1995, 274, 1800-4. Slide 2ɋ-26 Meta-Analyses and Systematic Reviews Systematic reviews and meta-analyses of RCT are of the highest level of reliability. A systematic review is a comprehensive review of the subject summarizing all previously performed trials of the highest level (most often - RCT), which were found, evaluated and then summarized by methodology. A meta-analysis is a review in which the results of all trials are combined and analyzed as one trial. A good systematic review or meta-analysis is a better guide to action than an individual article. SUNY Downstate Evidence Based Medicine Course. State University of New York, USA, 2002 Slide 2ɋ-27 Evaluating Thrombolytic Therapy for Myocardial Infarction In order to use the results of a meta- analysis, there a few key terms that should be understood. The odds ratio (OR) is the ratio of the odds or likelihood of an event occurring in one group to the odds of it occurring in another group. An odds ratio of 1 indicates that the condition or event under study is equally likely in both groups. An odds ratio greater than 1 indicates that the condition or event is more likely in the first group. An odds ratio less than 1 indicates that the condition or event is less likely in the first group. The dots on the graph indicate the odds of dying from a myocardial infarction. A confidence interval (CI) is an interval between 2 numbers with a similar probability or likelihood of happening. The horizontal line crossing the dot (odds ratio) is CI of that odds ratio or the range in which the true value of the indicator in the population may lie. The CI value characterizes the level of confidence of the study results. 2C - 14 Module 2C If the CI does not cross the line of 1, then all odds ratio values are either negative or positive. The trial results are statistically reliable. If CI crosses the line of 1, then relative risk may be both positive (the treatment is ineffective) and negative (the treatment is effective) values. Such results are considered statistically unreliable. In addition, the CI gives an idea about statistical power of the trial and helps to see its clinical significance. The narrower is the confidence interval, the stronger and more significant is the trial. A wide confidence interval indicates low strength of the trial most often caused by a small number of cases involved. Point out how, in the graph presented, the number of cases involved in the studies increases over time. When the number of participants is below 1-3 thousand, the CI is long or wide and sometimes crosses the line of one. As the number of patients involved in the trial increases, the CI becomes shorter or narrower and the reliability of obtained results increases. If, for example, the rate of the unwanted outcome (death, in this example) in the experiment group is 10%, while in the control group it is 20%, then the odds ratio of an unwanted outcome will be 0.10 / 0.20 = 0.50. The value of 0.50 is to the left of 1 on the chart indicating that the risk of the unwanted outcome in the experiment group is lower than that in the control group. In fact, the risk of the unwanted outcome in the experiment group is half (0.50) of the risk in, the control group risk. If, however, the rate of the unwanted outcome in the experiment group is higher than that in the control group (20% vs. 10%), the odds ratio of poor outcome will be 0.20 / 0.10 = 2.0. This is to the right of 1, indicating that the risk of poor outcome in the experimental group is greater than the risk of the outcome in the control group (in fact, it is twice as high). This indicates that the treatment is not only ineffective, but it is also harmful. If the rate of the poor outcome is identical in both groups, the odds ratio will be 0.20 / 0.20 = 1.0. The dot indicating the odds ratio value will be on the line of 1, indicating no difference in the rate of the unwanted outcome between the two groups. SUNY Downstate Evidence Based Medicine Course. State University of New York, USA, 2002 Slide 2ɋ-28 Cohort Studies Conducting a RCT is a very challenging task. Patients need to give informed consent to participate in a trial. RCTs can be expensive and can run the risk of being unethical – providing an experimental treatment to some and only giving a placebo to others. Therefore, evidence does also come from other types of studies such as cohort and case- control studies. However, the results of such studies are more subject to errors, thus their level of reliability is lower. A cohort study is a study in which patients 2C - 15 Effective Perinatal Care (EPC) are identified who already have a certain characteristic (exposure, disease, treatment, etc.) and are followed during some period of time. The outcomes are compared with patients who are similar but do not have that particular characteristic. For example, an RCT on the impact of smoking on health would not be ethical. You could not assign some people to smoke and others to not smoke, knowing that smoking has serious health consequences. A reasonable alternative is a cohort study. Two groups of people (cohorts) – smokers and non-smokers – are identified. Then these groups are followed for some period of time to identify any health problems. Cohort studies are not as reliable as RCT because the cohorts may be different in other ways than smoking. For example, smokers may be poorer or more overweight than non-smokers. This can exaggerate the differences between the groups and “mask” the specific effect of smoking. SUNY Downstate Evidence Based Medicine Course. State University of New York, USA, 2002 Slide 2ɋ-29 Case-Control Studies Case-control studies are retrospective studies of patients who already have a certain disease or condition. The researcher explores characteristics of these patients and tries to see how these patients differ from those who do not have the disease or outcome. For example, in a study on lung cancer, people with lung cancer are asked about their cigarette smoking practices. Their answers are then compared with those who do not have lung cancer. Case-control studies are less reliable than randomized or cohort studies because the correlation between conditions does not mean that one condition is caused by the other. For example, lung cancer occurs more often in people without university education (they are more likely to smoke), but this does not mean that receiving a university education will help to reduce the risk of lung cancer. The main advantages of a case-control study are: x The study can be done quickly. Researchers simply question patients about events in the past. Alternatively, researchers may take many years to discover this effect by themselves. x Researchers do not need any special methods, control groups, etc. They only select people who reveal a special condition, and ask them to answer several questions. SUNY Downstate Evidence Based Medicine Course. State University of New York, USA, 2002 2C - 16 Module 2C Slide 2ɋ-30 Clinical Cases Level C recommendations are based on data from descriptive studies without a control group – a series of clinical cases and individual clinical cases. An individual clinical case is a report of treatment of a single patient. A series of clinical cases consists of aggregated reports of treatment of a number of patients. For example, one of your patients has a condition that you have never seen before, and you are not sure what should be done for this patient. Looking for the series of clinical cases will help you to diagnose. Data from clinical case or a series of cases provide less reliable results. For common conditions it is worthwhile to look for more reliable evidence. SUNY Downstate Evidence Based Medicine Course. State University of New York, USA, 2002 Slide 2ɋ-31 What Is Evidence-Based Medicine? “Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer.” Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. Depending on the circumstance, one component sometimes plays a more dominant role than others in making an important decision, although ideally all components are involved. Evidence- based medicine assists clinicians in daily practices where there are doubts about the correlation 2C - 17 Effective Perinatal Care (EPC) or association between risks, and benefits. Alternatively, that which is theoretically black and white can quickly become grey in practice when a clinician is solving the problems of a particular patient. The term “evidence-based medicine” was proposed in 1988 by clinicians and epidemiologists at the McMaster University in Canada. It became universally known in 1990s. During the last two decades, support for “evidence-based medicine” has grown rapidly around the world. Today clinicians in most western countries are trained to make evidence-based decisions, while governments, health professionals, and the health industry actively develop the structure and procedures to support evidence-based decisions. The key is that evidence-based medicine improves safety and effectiveness of healthcare. Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. Evidence-based medicine. A new approach to teaching the practice of medicine. Evidence-Based Medicine Working Group. JAMA, 1992, Vol. 268, Issue 17, 2420-2425. Slide 2ɋ-32 When Did Evidence-Based Medicine Emerge? Archie Cochrane described a way of bringing scientific trials to the attention of clinicians and making the results a stimulus for discussion and careful analysis. His efforts with colleagues from the British Medical Research Council made a substantial contribution to what is now named evidence-based medicine. Cochrane’s joint work with other researchers is a blend of voluntary effort and support from the whole world. The goal is to develop an information database pulling the information from the best RCTs. The idea was that if all information were in one place and available for clinicians, it would facilitate evidence-based decision-making. The first documented RCT was conducted in 1940 on the use of streptomycin for tuberculosis treatment. In 20 years, as a result of the “thalidomide tragedy,” the research community focused its attention on the thousands of newborns with heavy congenital malformations. Early in 1962, the Medicine and Nutrition Control Committee demanded “controlled trials” to prove the safety and effectiveness of new treatment. Attention was mainly directed at drugs, thus interventions and diagnostics were out of focus, until epidemiologist Archie Cochrane claimed in 1971 that contemporary medicine lacks evidence and it may be even harmful. Furthermore, a critical trial in 1974 showed that what was known about medicine was not systematized across all manuals and guidelines. In the 1980s and early 1990s the focus was on identifying the rules of systematic reviews and on finding funds for clinical guidelines development. In general, it took several years to develop clinical guidelines from different sources. By the time of publication, the guidelines would already be out-of-date and very often did not represent real world practices. Therefore, such guidelines were not strictly observed. 2C - 18 Module 2C Slide 2ɋ-33 Five Steps of Evidence- Based Medicine "Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgement that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer". Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. “Evidence-based medicine (EBM) involves caring for patients by explicitly integrating clinical research evidence with pathophysiologic reasoning, caregiver experience, and patient preferences... EBM is a style of practice and teaching which may also help plan future research". Cook, DJ and Levy MM. Evidence-based medicine. A tool for enhancing critical care practice. Crit Care Clin, 1998, 14, 353-8. In practice, implementing evidence-based medicine consists of five steps: 1. Ask an answerable clinical question in the PICO format (patient, intervention, comparison, outcomes). This allows for identification of key words used in the search for evidence. 2. Search for the best evidence. Start by searching for systematic reviews and RCTs since they are the most reliable and valuable trials. If no such studies are found, start looking for evidence of a lower level (lesser reliability): cohort studies, case-control studies, case series studies, etc. 3. Critically evaluate the evidence. This is a very important step which involves determining the reliability of the evidence found (was the study correctly conducted? is it trustworthy? is it valid?) and the results of the trial (how effective is this treatment or prevention? how precise is this method of diagnostics?). To check the reliability of a RCT, the following questions should be answered: x Were the patients randomized? x Did all group participants complete the trial (completeness)? 2C - 19 Effective Perinatal Care (EPC) x Were the patients analyzed by groups of randomization? x Was the trial blind both for the patients and the researchers? x Were the groups identical at the beginning of the trial? x Besides experimental intervention, did the groups receive similar treatment? If the trial is of high quality, that is, if it is reliable, its results are evaluated. 4. Consider the evidence in terms of clinical expertise and patient’s needs. 5. Assess the feasibility of implementing the evidence-based technologies. Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. Rosenberg W, Donald A. Evidence based medicine: an approach to clinical problem solving. BMJ, 1995, 310, 1122-1126. Cook, DJ and Levy MM. Evidence-based medicine. A tool for enhancing critical care practice. Crit Care Clin, 1998, 14, 353-8. Slide 2ɋ-34 Evaluating Current Practices In the course of this training, the existing practices will be assessed using the following questions about current practices: x What procedures am I performing? x Why am I performing this procedure? Which results do we expect from performing this procedure? x Will this procedure reach my goal? What is the evidence of effectiveness (and safety) of this procedure? x Is there a better or more acceptable way of reaching my goal? Are there any other more effective or safer procedures (treatments)? Slide 2ɋ-35 Mastering Evidence-Based Medicine Clinicians need special skills and adequate time to search and critically analyze available evidence. It is much easier to use summaries of evidence- based medicine developed by specialists (Cochrane database, WHO Reproductive Health Library, “The Guide on Effective Care in Pregnancy and Childbirth” by M. Enkin et al., 2000) or clinical guidelines and protocols. 2C - 20 Module 2C Slide 2ɋ-36 An Example of Implementing a Technology of Demonstrated Effectiveness “I think it’s particularly amazing that the information on the cure of scurvy was available a long time before it was acted upon.” Mark R. Anderson. A Short History of Scurvy. 2000 "Evidence-based medicine is not "cook- book" medicine. Because it requires a bottom-up approach that integrates the best external evidence with individual clinical expertise and patient-choice, it cannot result in slavish, cook-book approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision. Evidence-based medicine is not cost-cutting medicine. Some fear that evidence-based medicine will be hijacked by purchasers and managers to cut the costs of health care. This would not only be a misuse of evidence-based medicine but suggests a fundamental misunderstanding of its financial consequences. Doctors practising evidence-based medicine will identify and apply the most efficacious interventions to maximise the quality and quantity of life for individual patients; this may raise rather than lower the cost of their care". Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. Mark R. Anderson. A Short History of Scurvy. 2000 Slide 2ɋ-37 Modified Antman’s Table The Antman table visually illustrates the considerable delay in the appearance of reliable evidence of treatment effectiveness and its introduction in curriculum for heath professionals and, consequently, in routine clinical practices. The table consists of two adjacent parts: the left part is the graph showing the growth of reliability of evidence on thrombolytic therapy of myocardial infarction. As the number of trials on this issue and the number of patients involved increases, confidence intervals narrows, and the ɪ-value becomes less. The right side indicates the number of manuals issued during a certain period of time. x Column 4 – the number of manuals in which thrombolytic therapy is not described at all x Column 3 – number of manuals mentioning the experimental use of thrombolytic therapy for myocardial infarction x Column 2 – the number of manuals which consider the possibility of the use of thrombolytic therapy x Column 1 – the number of guidelines which recommend thrombolytic therapy. 2C - 21 Effective Perinatal Care (EPC) According to the table, in the late 60s and early 70s, when there was little evidence of effectiveness of thrombolytic therapy for myocardial infarction, the guidelines issued either did not mention this treatment or stated that the trials were being conducted on the use of thrombolytic therapy for myocardial infarction. By the end of the 70s and beginning of 80s over thousands of patients participated in trials on thrombolytic therapy for myocardial infarction. The ɪ-value dropped much below 0.001. In other words, the effectiveness of this method is highly reliably. However, no guidelines recommending this technology were issued during this period of time, and only three guidelines discuss the possibility of implementing this practice. The first guidelines recommending thrombolytic therapy appeared in mid 1980s, 15 years after the effectiveness of this treatment was proven. The most interesting thing is that even in the early 90s, when the number of patients participating in trials reached 50.000 at ɪ<0.00001, guidelines were still published which did not describe thrombolytic therapy for myocardial infarction. Antman EM et al. A comparison of results of meta-analyses of randomized control trials and recommendations of guidelines on same issue. JAMA 1992, 268, 240-8. Slide 2ɋ-38 Effective Interventions with Limited Implementation This table presents a number of technologies of proven effectiveness which have limited or rare implemented around the world. Duley L, Gülmezoglu AM, Henderson- Smart D. Magnesium sulphate and other anticonvulsants for women with pre- eclampsia. In: The Cochrane Library, Issue 2, 2003. Prendiville WJ et al. Active versus expectant management in the third stage of labour. The Cochrane Database of Systematic Reviews, 2000, Issue 3. Hodnett, E. D. et al. Continuous support for women during childbirth. The Cochrane Database of Systematic Reviews, 2004, Issue 1. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. "Evidence-based medicine is not restricted to randomised trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.....if no randomised trial has been carried out for our patient's predicament, we follow the trail to the next best external evidence and work from there". Sackett DL et al. Evidence based medicine: what it is and what it isn't. BMJ, 1996, 312, 71-72. 2C - 22 Module 2C Slide 2ɋ-39 Common Interventions with Limited Effectiveness Many medical interventions or technologies which have limited effectiveness (offering limited or no protection) are still commonly implemented. Bricker L, Neilson JP. Routine Doppler ultrasound in pregnancy. The Cochrane Database of Systematic Reviews, 2000, Issue 2. Katherine Hartmann et al. Outcomes of Routine Episiotomy. A Systematic Review. JAMA. 2005, Vol. 293, No. 17, 2141-2148 Pattison N, McCowan L. Cardiotocography for antepartum fetal assessment. The Cochrane Database of Systematic Reviews, 2005, Issue 4. Basevi V, Lavender T. Routine perineal shaving on admission in labour. The Cochrane Database of Systematic Reviews, 2005, Issue 4. Cuervo LG, Rodríguez MN, Delgado MB. Enemas during labour. The Cochrane Database of Systematic Reviews, 2007, Issue 1. Slide 2ɋ-40 Conclusions "Evidence-based health care is the conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services. Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of health care, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors." First Annual Nordic Workshop on how to critically appraise and use evidence in decisions about healthcare, National Institute of Public Health, Oslo, Norway, 1996 2C - 23 Effective Perinatal Care (EPC) Slide 2ɋ-41 “A Guide to Effective Care in Pregnancy and Childbirth” This Guide compiles different evidence- based midwifery and obstetrical technologies. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000 Slide 2ɋ-42 What Is Unusual about This Guide? Slide 2ɋ-43 Guide Synopses In the final chapter of this guide authors have tried to summarize the main conclusions reached in earlier chapters. This summary takes the form of six tables. 2C - 24 Module 2C Slide 2ɋ-44 Case Study Slide 2ɋ-45 Case Study (cont.) Slide 2ɋ-46 Clinical Question 2C - 25 Effective Perinatal Care (EPC) Slide 2ɋ-47 Question: Diagnosis Slide 2ɋ-48 Scientific Evidence Slide 2ɋ-49 Clinical Question 2C - 26 Module 2C Slide 2ɋ-50 Question: Treatment Slide 2ɋ-51 Scientific Evidence Slide 2ɋ-52 Question: Treatment 2C - 27 Effective Perinatal Care (EPC) Slide 2ɋ-53 Scientific Evidence Slide 2ɋ-54 Clinical Question Slide 2ɋ-55 Question: Basic Risk 2C - 28 Module 2C Slide 2ɋ-56 Scientific Evidence Slide 2ɋ-57 Possible Solutions for Treating Hyperbilirubinemia in Healthy Neonates (1) Slide 2ɋ-58 Possible Solutions for Treating Hyperbilirubinemia in Healthy Neonates (2) 2C - 29 Effective Perinatal Care (EPC) Slide 2ɋ-59 Possible Solutions for Treating Hyperbilirubinemia in Healthy Neonates (3) Slide 2ɋ-60 Conclusion to the Clinical Case 2C - 30 Module 3C Counselling Skills in Maternal and Neonatal Care Effective Perinatal Care (EPC) 3C - 2 Module 3C Slide 3C-1 Counselling Skills in Maternal and Neonatal Care Module objectives: At the end of the module the participants will be able to: x Define counselling and its role in improving medical care x Identify the level of information the user possesses and the user’s needs x Characterize effective counselling focusing on the needs of the family and the woman x Demonstrate effective communication skills including non-verbal, open-ended questions, paraphrasing the user, using non-judgmental words x Use “listen and recognize” communication skills A health professional should have good communication and counselling skills. Slide 3C-2 Effective Communication Communication is not the same as giving advice. When giving advice, the doctor takes the responsibility for the decision-making, whereas counselling results in the users making an informed decision based on all the information available. Health care workers should provide complete information to the user. The health care worker should not push the user regarding a specific care or treatment option. Northouse, L.L., Northouse, P.G. Health Communication: Strategies for Health Professionals. 3rd edition. Stamford, 1998. Slide 3C-3 Communication Methods We will learn how to use effective verbal and non-verbal communication in the course of providing effective perinatal care. The use of audio–visual communication will not be discussed in detail, although these methods are also effective and can be used in counselling. 3C - 3 Effective Perinatal Care (EPC) Slide 3C-4 Guidelines for Effective Verbal Communication (1) Skills of effective verbal communication: x Listen actively/be attentive; x Show your interest; x Support the user’s feelings and maintain the spirit of the conversation; x Ask questions Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 3C-5 Guidelines for Effective Verbal Communication (2) A common complaint of users regarding the quality of health care is that health care workers do not want to communicate with them, do not want to listen to them and do not understand their needs. Health care workers do not always demonstrate good communication skills but they are expected to possess an understanding attitude. The providers’ lack of understand can be detrimental to the user’s health. Avoid asking questions that could suggest the right answer. Avoid questions that can be simply answered by ‘yes’ and ‘no’. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 3C-6 Guidelines for Effective Non-Verbal Communication It is important to create an informal space during counselling and keep an appropriate distance between people. The distances could be as follows: x Intimate distance (up to 45 cm) is suitable for personal conversations between friends, parents and children; x Professional distance (45 cm to 1.2 m) is suitable for counselling; 3C - 4 Module 3C x Social distance (1.2 m to 3.5 m) is maintained during business meetings; x Public distance (5 m and more) Page K. Pressly, Martin Heesacker. The Physical Environment and Counseling: A Review of Theory and Research. Journal of Counselling & Development, 2001, Volume 79, Number 2, 148 – 160. Slide 3C-7 Counselling One of the key indicators of high quality maternal and infant health care is the provider’s ability to communicate, listen and understand the user’s needs and to use this information for effective care. Counselling should address the needs of the woman and her family; confidentiality is a key component of this. This is a dialog, not a lecture. The health care worker does not judge the user and allows the user to speak freely. The health care worker should present multiple options but should not push the user regarding specific care or treatment. The priorities are identified by the user, rather than dictated by the health care worker. Slide 3C-8 Types of Counselling Family counselling is a type of individual counselling. 3C - 5 Effective Perinatal Care (EPC) Slide 3C-9 Counselling Steps Counselling provides complete information to the user helping him/her to make an informed choice regarding future actions. During the counselling session, users have an opportunity to look at the situation from a different point of view, to evaluate the impact of their actions differently and in order to change their behaviour and make positive decisions. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 3C-10 Counselling Is a Combination of: The effectiveness of counselling depends on trust between the counsellor and the user. Trusting relations are built on: x Understanding of human relations: kindness, politeness, and compassion x Professionalism (knowledge) – having correct and detailed information, addressing complicated questions x Use of effective counselling skills Slide 3C-11 Counselling Skills Skill 1: Using effective non-verbal communication Skill 2: Asking open-ended questions Skill 3: Showing interest Skill 4: Paraphrasing the user Skill 5: Showing that you understand the user’s feelings Skill 6: Avoiding the use of judgmental words 3C - 6 Module 3C Slide 3C-12 Skill 1: Using Effective Non-Verbal Communication Posture: x Facilitates communication – you are sitting and your head is on the same level as user’s head x Does not facilitate communication – you are standing and your head is above your user’s head x Avoid defensive postures, for example crossed arms Paying attention: x Facilitates communication – maintain eye contact with the user; x Does not facilitate the communication – looking around the room, avoiding looking at the woman, focusing on only writing notes Removing the barriers: x Facilitates communication – there should be no desk between the counsellor and user; the counsellor should sit near the woman and put the notes aside; x Does not facilitate communication – counsellor is sitting behind the table, writing during the conversation, etc. No rushing: x Facilitates communication – greet the user without rushing, sit down to talk to the user, If necessary, stand close to the user and wait patiently for the answers; x Does not facilitate the communication – being rush, acting impatiently, watching the clock, pushing the user towards the entrance, etc. x Touch in an appropriate way – try not to touch uncovered areas of the body. Cynthia H. Adams, Peter D. Jones. Interpersonal communication skills for health professionals. 2-d edition. Glencoe/McGraw-Hill, 2000. Slide 3C-13 Skill 2: Asking Open- Ended Questions Ask questions with an intonation that demonstrates your interest and friendliness to the user. Ask one question at a time and wait for the answer with interest. When you ask a delicate question, explain why you are doing so. Avoid questions that start with the words ‘why?’ and ‘what for?” – sometimes they sound as if you are accusing the user. If the user does not understand you, ask your question using different words. Close-ended questions result in only ‘yes’ or ‘no’ answers. Rinehart, W., Rudy, S., Drennan, M. GATHER Guide to Counselling. Population Reports, John Hopkins University School of Public Health, Population information program, Baltimore, Series J, 1998, Number 48. 3C - 7 Effective Perinatal Care (EPC) Slide 3C-14 Exercise: Creating Open- Ended Questions All the questions on the slide are closed- ended questions. How would you change each sentence to make it an open-ended question? Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 3C-15 Skill 3: Showing Interest If you want the user to continue to discuss issues with you, you have to show her that you are listening to her and that you are interested in what she is saying. You can use the following words, “really?”, “and than?” etc. These words encourage the woman to continue the conversation. Use encouraging gestures when talking to the user (look, nod, and smile) Negative gestures: shrugging your shoulders may mean “I do not care”. Swinging your head back and forth may indicate “That is not correct.” The gestures the counsellor uses should be culturally appropriate. For example: When a person makes a circle using the thumb and the pointer finger it means “OK – it is all right” in the USA; “0 – it is not worthy” in France; It is a vulgar and inappropriate gesture in Germany, Brazil, and Australia. Roger E. Axtell. Do's and Taboos of Humor Around the World: Stories and Tips of Business and Life. 1999. 3C - 8 Module 3C imagine that your labour was very painful.” Slide 3C-16 Skill 4: Paraphrasing the User’s Words It is important to paraphrase the user’s words by repeating them during counselling. For example: If the user says “I am worrying about how painful the birth will be.” The health care worker may paraphrase the words: “It sounds like you are worried that the upcoming birth will be painful?” Cynthia H. Adams, Peter D. Jones. Interpersonal communication skills for health professionals. 2-d edition. Glencoe/McGraw-Hill, 2000. Slide 3C-17 Exercise: Paraphrasing the Words of the User Paraphrase each of the following sentences. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 3C-18 Skill 5: Showing that You Understand the User’s Feelings Empathic reaction – feeling compassion for another person out of past personal experience. It is important the user feels the counsellor is interested in her condition, even if she has no problems. Perspective – putting yourself in the other person’s shoes, trying to understand something from the user’s perspective, for instance, the woman complains ”I have had a very painful labour”. the counsellor could say “I can 3C - 9 Effective Perinatal Care (EPC) Sympathetic reaction – feeling compassion for another out of concern for that person, for instance, the user’s baby is in critical condition, the counsellor could say “I understand how difficult this is for you – you must be worried about your child?” Cynthia H. Adams, Peter D. Jones. Interpersonal communication skills for health professionals. 2-d edition. Glencoe/McGraw-Hill, 2000 Slide 3C-19 Skill 6: Identifying Judgmental Words Judgmental words can be more common in close-ended questions. Asking open-ended questions can help to avoid using judgmental words. Judgmental words can imply that the counsellor is evaluating the user’s behaviour. Use of judgmental words may lead the user to feel uncomfortable. The user might think that the counsellor does not care about her and/or her baby. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 3C-20 Exercise: Identify Judgmental Words Restate each sentence avoiding the use of judgemental words. Breastfeeding counselling: Training course. WHO, UNICEF,1993. 3C - 10 Module 3C Slide 3C-21 Summary: Counselling Skills All health care workers should have basic counselling skills (non-verbal communication skills, ability to ask open- ended questions, ability to show interest in the user, ability to paraphrase the user, avoidance of the use of judgemental words). Breastfeeding counselling: Training course. WHO, UNICEF, 1993. Slide 3C-22 Qualities of Good Counsellor Supportive reactions show that we worry for the interlocutor and for what has happened and that we have the empathic reaction towards this person regardless of the direction and intensity of his feelings. Although people differ in their ability for empathic reaction most of us should have learned to improve this ability and use it in the future. For those who are self-centred, it will be very difficult to see the world from another person’s point of view. Our ability to empathy is often underdeveloped. It might sound banal but the first step to improve your empathy is to show your respect to those speaking. Respect is an attentive and serious attitude to what the other people are saying and to their feelings. It starts with considering the person as a complete personality with own values and not simply as an object. Respect of others focuses your energy on others and not only on yourself. Adrianne W. Kunkel, Brant R. Burleson. Assessing Explanations for Sex Differences in Emotional Support. A Test of the Different Cultures and Skill Specialization Accounts. Human Communication Research, 1999, Volume 25, Number 3, 307–340. 3C - 11 Effective Perinatal Care (EPC) 3C - 12 Module 4C Assessment of Foetal Well-Being During Pregnancy and Labour and Assessment of Small for Gestational Age (SGA) Foetuses Effective Perinatal Care (EPC) 4C - 2 Module 4C 4C - 3 Slide 4C-1 Assessment of Foetal Well- Being During Pregnancy and Labour and Assessment of Small for Gestational Age (SGA) Foetuses Obstetricians and midwives are accustomed to classifying abnormal foetal conditions with various terms (foetal distress, foetal / perinatal anoxia / hypoxia, foetal growth restriction, foetal impairment, foetal acidemia, fetoplacental deficiency, etc…), using different tests, following different classifications and strictly relating such foetal “conditions” with neonatal outcomes. The aim of this module is clarify these definitions and essential tests and therapies for normal and IUGR pregnancies. Learning objectives: x Be able to give the following definitions: o Intrauterine Growth Retardation o Small for Gestational Age Foetus o Nonreassuring Foetal Status x Understand that the terms “foetoplacental deficiency” and “foetal hypoxia” are non-diagnostic pathophysiological and metabolic processes, and that they are one of the key causes for antenatal hospitalization and unnecessary interventions during pregnancy in Eastern European countries. x Know the main risk factors for IUGR and conditions that need dynamic antenatal examination. x Learn and be able to use and correctly interpret the main antenatal diagnostic tests that are used to improve perinatal outcomes. Clearly understand clearly that they are minimally effective for low-risk pregnant women. x Think critically about the current technologies used to improve foetal well-being in the uterus and treatment of IUGR. Understand that most of these technologies are unsafe and have limited effectiveness. Slide 4C-2 Questions for the Groups Effective Perinatal Care (EPC) Slide 4C-3 Obstetricians Can Determine Certain Specific Things about a Foetus Given an improved understanding of fetal physiology, an obstetrician can now ask specific questions about the status of a fetus. Is it healthy? Is it tolerating its environment and thriving? Is it safe to remain in utero? Is it safe for it to be born? Recent advances in obstetrical technology have provided some answers to these questions. Meier PR, Makowski EL. The antepartum assessment of fetal well-being (Medical Progress). West J Med, 1983 May;138:686-689. Slide 4C-4 The Aims of Antenatal Care The aim of antenatal care (ANC), of which assessment of foetal well-being is a part, is to help women stay healthy by discovering and correcting adverse conditions, thus helping the health of the foetus. WHO Regional Office for Europe. Health Evidence Network report. What is the effectiveness of antenatal care? 2005 Slide 4C-5 Definition of Small for Gestational Age (SGA) Foetus (1) SGA refers to a foetus that has failed to achieve a specific anthropometric or estimated weight threshold by a specific gestational age. The commonly used threshold is the 10th percentile for abdominal circumference and estimated birth weight (as recommended by WHO). SGA foetuses are a heterogeneous group comprised of foetuses that have failed to achieve their growth potential (intrauterine growth restriction (IUGR) or foetal growth restriction (FGR)) and foetuses that are constitutionally small. 4C - 4 Module 4C The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Medical literature references to underweight infants date back to 1919, when it was suggested that all newborns weighing less than 2.500 g (5 lb, 8 oz) should be classified as "premature." However, it was not until 1961 that the World Health Organization (WHO) acknowledged that many infants defined as "premature" were not born early but were simply of "low birth weight." The current WHO criteria for low birth weight is a weight less than 2.500 g (5 lb, 8 oz) or below the 10th percentile for gestational age. Vandenbosche RC, Kirchner JTR. Intrauterine growth retardation. Am Fam Physician. 1998 Oct 15;58(6):1384-90 Slide 4C-6 Antenatal Growth Chart Measuring fundal-symphyseal height and charting its growth on an antenatal growth chart is a simple and inexpensive method- of-choice for antenatal care. This method enables diagnosing small or large foetus size for the corresponding gestational age, however it does not always indicate pathology. Belizán J et al. Diagnosis of intrauterine growth retardation by a simple clinical method: measurement of uterine height. American Journal of Obstetrics and Gynecology, 1978, 131: 643–646. Slide 4C-7 Association between Birth Weight and Perinatal Mortality and Morbidity This figure shows the increase in morbidity and mortality by birth weight percentile. The sharpest increase in morbidity rate is in the group of babies with a birth weight below the 7th percentile. However, some neonates with a birth weight below the 10th percentile are healthy. McIntire DD, Bloom SL, Casey BM, Leveno KJ. Birth weight in relation to morbidity and mortality among newborn infants. N Engl J Med. 1999 Apr 22;340(16):1234-8 4C - 5 Slide 4C-8 Definition of Small for Gestational Age (SGA) Foetuses (2) Effective Perinatal Care (EPC) The term “low birth weight” covers two pathological conditions and one normal condition. “Normal condition” refers to a healthy but constitutionally small baby. Pathological conditions include preterm birth and intrauterine growth retardation (IUGR). Synonymous terms found in the medical literature to describe infants with IUGR include: intrauterine growth restriction and foetal growth retardation. Out of all foetus below the 10th percentile: x 40% have a high risk of perinatal mortality x 40% are small by constitution x 20% of SGA are caused by chromosome or ecological aetiology The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Newborns with IUGR have a much higher chance of dying or suffering respiratory distress syndrome, developing such complications as intraventricular haemorrhages and necrotic enterocolitis. Relative risks of complications: x RR of death - 2.77 (CI= 2.31-3.33) x RR of respiratory distress syndrome - 1.19 ( CI= 1.03-1.29) x RR of intraventricular hemorrhage - 1.13 ( CI= 0.99-1.29) x RR of necrotizing enterocolitis - 1.27 ( CI= 1.05-1.53) Bernstein IM, Horbar JD, Badger GJ, Ohlsson A, Golan A. Morbidity and mortality among very-low-birth-weight neonates with intrauterine growth restriction. The Vermont Oxford Network. Am J Obstet Gynecol. 2000 Jan; 182(1 Pt 1):198-206 Approximately one quarter of all newborns below the 10th percentile have normal weights in relation to the weight of the mother, the father’s phenotype, geographical location, race, etc. Vandenbosche RC, Kirchner JTR. Intrauterine growth retardation. Am Fam Physician. 1998 Oct 15;58(6):1384-90 Slide 4C-9 Predisposing Factors for IUGR There are several types of factors predisposing foetuses to IUGR, but key ones are divided into 4 groups: maternal, placental, environmental, or genetic. Maternal factors include: small size of the mother; previous delivery with low birth weight; multiple pregnancy; multiparity; malnutrition; abnormal shape or size of the uterus; bleeding during pregnancy; health of the mother; over- term pregnancy; maternal infections during pregnancy (syphilis, herpes, rubella, toxoplasmosis, hepatitis); cardiovascular issues (high blood pressure, some cardiac diseases, pre-eclampsia or eclampsia); diabetes mellitus and gestational diabetes; AFS (antiphospholipid syndrome); and any chronic or prolonged disease in the mother (e.g., sickle- cell anaemia, system diseases, pulmonary diseases with respiratory compromise, renal diseases, etc.). 4C - 6 Module 4C 4C - 7 Placental factors include placenta and cord-related defects limiting foetal blood supply. For example, blood supply can decrease because there is a single umbilical artery instead of two. It can also be limited due to some cord compression or entwinement around some part of the foetal body. Blood supply may decrease due to an actual or effective knot of the cord. Structural anomalies and placental malformations can lead to placental blood flow disorders. Insufficient mass and surface of the placenta (less than 8% of the newborn body weight) are an important risk factor for IUGR, as well as abnormal placental attachment (low attachment, presentation). Environmental factors: some drugs (such as Coumadin (warfarin) and Dilantin Hydantoin (phenytoin)), or other agents used by the mother, may have a direct impact on the foetus: smoking, alcohol, cocaine, living at a high altitude (above 3000 m above the sea level). Genetic (foetal) factors include genetic and chromosomal disorders, as well as inborn defects: trisomy of the 13th chromosome (Patau syndrome), 18th chromosome (Edwards syndrome) or 21st chromosome (Down syndrome); 22 autosomal pairs; Turner’s syndrome (45 ɏɈ), a third set of chromosomes, or additional ɏ or Y chromosomes. Terry Harper et al. Fetal Growth Restriction. August 2005 http://www.emedicine.com/med/topic3247.htm Slide 4C-10 Interventions for Prevention of IUGR Unfortunately, many causes of IUGR cannot be treated antenatally. Today, the majority of perinatal interventions aiming to improve foetal growth and prevent foetal distress do not show good results in terms of perinatal outcomes. A study of the effectiveness of bed rest (n=107) found: x Foetal weight abnormality was 21.7% below normal for the bed rest group and 20.7% below normal for the mobile group. x The average birth weight for the bed rest group was 19.7% below normal and 20.6% below normal for the mobile group. There were no differences identified between bed rest and mobile groups for growth parameters and other newborn-related results (RR= 0.43, with CI 95%: 0.15 to 1.27). A meta-analysis of 13 trials assessing the impact of aspirin in preventing foetal growth retardation found that aspirin does prevent IUGR in a high-risk group. The latest studies were small and they show inconclusive results. There is insufficient evidence to evaluate the need to prescribe oxygen therapy, diet therapy, hospitalization, bed rest, betamimetics, calcium channels blockers, hormonal therapy, increase in plasma volume, or barotherapy for IUGR. There is also insufficient evidence to support the use of piracetam for pathological condition of the foetus during labour. Harrington K, Kurdi W, Aquilina J, et al A prospective management study of slow-release aspirin in the palliation of uteroplacental insufficiency predicted by uterine artery Doppler at 20 weeks Effective Perinatal Care (EPC) . Ultrasound Obstet Gynecol 2000 15 (1): 13-8 Hofmeyr GJ, Kulier R Piracetam for fetal distress in labour (Cochrane Review) Cochrane Database Syst. Rev. 2006 Slide 4C-11 Tests Used in ANC to Assess Foetal Well-Being Slide lists routine tests used to assess foetal well-being. Slide 4C-12 Assessment of Foetal Activity - Movement Counting There is often no obvious cause of late fetal death of normally formed singleton births. Many of these deaths are unpredictable and occur in women who are healthy and whose pregnancies have been otherwise uncomplicated. Maternal recognition of decreased foetal movement has long been used during antenatal care in an attempt to identify the jeopardised foetus and intervene to prevent death. Given the low prevalence of foetal compromise and an estimated specificity of 90% to 95%, the positive predictive value of the maternal perception of reduced foetal movements for foetal compromise is low, between 2% to 7%. One RCT assessed the ability of the ‘count to ten’ method to reduce the prevalence of antenatal foetal death. Women recorded the amount of time it took to feel ten foetal movements each day. This cluster RCT randomised 68,000 women to either routine formal foetal-movement counting or to standard care. There was no decrease in perinatal mortality in the test group, and this protocol would have to be used by about 1250 women to prevent one unexplained death. The evidence does not support the routine use of formal foetal movement counting to prevent late foetal death. If women notice a reduction in foetal movements, they should contact their midwife or hospital for further assessment. Routine care for the healthy pregnant woman. Antenatal care Clinical Guideline # 6. National Institute for Clinical Excellence. 4C - 8 Module 4C October 2003 Slide 4C-13 Auscultation of Foetal Heart Beat Auscultation of the foetal heart may confirm that the foetus is alive but is unlikely to have any predictive value. Routine listening is therefore not recommended. However, if the mother requests it auscultation of the foetal heart may provide reassurance. Routine care for the healthy pregnant woman. Antenatal care Clinical Guideline # 6. National Institute for Clinical Excellence. October 2003 Auscultation was one of the first methods used to check for life. Many clinicians in different parts of the world hoped that it would become an effective means to reveal foetal disorders. In approximately two centuries of use there have been no randomized controlled trials to study the effectiveness of auscultation. It was shown that there is no association between auscultated heartbeat rate and health of the foetus, excluding the extreme stage. The extreme stage means terminal bradycardia. Auscultation of foetal heartbeat must be conducted if a woman requests it. This will increase her satisfaction with antenatal care. Parer JT, King T. Fetal heart rate monitoring: is it salvageable? Am J Obstet Gynecol. 2000 Apr;182(4):982-7 Slide 4C-14 Ultrasounds Routine ultrasounds in early pregnancy (before 24 weeks) are effective in assessing gestational age, early detection of multiple pregnancies and early detection of unpredicted foetal malformation at a time when termination of pregnancy is possible. Routine ultrasounds in late pregnancy for low-risk women or unselected populations do not benefit the mother or the baby. What is the effectiveness of antenatal care? WHO Regional Office for Europe - Health Evidence Network report 2005 4C - 9 Slide 4C-15 Common Tests Used in ANC to Detect SGA Methods employed to detect SGA foetuses include abdominal palpation, measurement of symphyseal-fundal height, ultrasound biometry, ultrasound estimated foetal weight and ultrasound Effective Perinatal Care (EPC) Doppler flow velocimetry. Four important issues need to be considered with the use of these tests: x Most measurements require an accurate estimation of gestation as a prerequisite x Most tests attempt to diagnose SGA foetuses rather than growth-restricted foetuses x Most studies use one-time measurement (size) to predict SGA while there is evidence that it is the trend (growth) that is of more value in predicting poor foetal outcomes x In most situations no allowance is made for important prognostic factors for SGA, such as maternal height, weight, ethnicity, parity or foetal gender. It should also be noted that, although an individual test alone may not be predictive of SGA or FGR, a composite of abnormal results may. Pathology might be indicated by an ultrasound showing a small foetus with reduced liquid or an abnormal uterine artery Doppler. A distinction should be made between biometric tests (tests to measure size) and biophysical tests (tests to assess foetal wellbeing). Biometric tests are designed to predict size and, if performed longitudinally, growth, but not wellbeing. Biophysical tests, on the other hand, are not designed to predict size but they do predict foetal wellbeing. The presence of foetal wellbeing implies the absence of foetal acidaemia. This distinction implies that the diagnosis of SGA would rely on biometric tests while abnormal biophysical tests are more indicative of FGR than SGA. To assess foetal well-being, biometric diagnostic tests are used, including: dynamic fundal- symphysial height measurement, ultrasonographic examination to assess the weight of the baby and status of the placenta; biophysical tests including: non-stress cardiotocography test, foetal biophysical profile score and modified foetal biophysical profile score (ultrasonographic assessment of foetal activity and / or amniotic fluid volume), and Doppler velocimentry of the umbilical artery. Fetal Health Surveillance In Labour SOGC Clinical Practice Guidelines NO. 112. 2002 The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists November 2002 Slide 4C-16 Abdominal Palpation Abdominal palpation has limited diagnostic accuracy to predict an SGA foetus. (A) The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists., November 2002 4C - 10 Module 4C 4C - 11 Slide 4C-17 Fundal Height Measurement Single fundal height (FH) measurement has limited diagnostic accuracy to predict an SGA neonate. It has limited diagnostic reliability (sensitivity - 27%, specificity – 88%) and does not decrease perinatal mortality. Use of a customised fundal height chart improves accuracy. A series of measurements (fundal-symphysial height measurement chart) increases sensitivity (up to 49%) and specificity to predict an SGA fetus. Pearce JM, Campbell S. A comparison of symphysis-fundal height and ultrasound as screening tests for light-for-gestational age infants. BJOG 94: 100-104 1987 Neilson JP. Symphysis-fundal height measurement in pregnancy (Cochrane Review) In: The Reproductive Health Library, Issue 8, 2005 Persson B, Stangenberg M. Prediction of size of infants at birth by measurement of symphysis fundus heigh. BJOG 93: 206-211 1986 The investigation and management of the small for gestational age fetus Royal College of Obstetricians and Gynaecologists, November 2002 Gardosi, Jason & Francis, Andre. Controlled trial of fundal height measurement plotted on customised antenatal growth charts. BJOG 106: 309-317 1999 Slide 4C-18 Fundal Height Measurement – Is a SGA Foetus Present? Effective Perinatal Care (EPC) Slide 4C-19 Use of Antenatal Growth Chart Growth dynamics are more important than the absolute values of fundal-symphysial height. Slide 4C-20 Ultrasound Biometry Abdominal circumference (AC) and estimated fetal weight (EFW) are the most accurate diagnostic measurements to predict SGA. In high-risk women, AC below the tenth percentile has sensitivities of 72.9–94.5% and specificities of 50.6– 83.8% in the prediction of foetuses with birth weight below the tenth percentile. The respective figures for EFW are sensitivities of 33.3–89.2% and specificities of 53.7–90.9%. A systematic review by Chang et al. found that a threshold of the tenth percentile had better sensitivities and specificities than other commonly used percentiles. Another study where receiver operator curves were used to determine the cut-off to obtain the best sensitivities and specificities found the customised eighth percentile for EFW to be the optimal threshold to predict operative delivery for foetal distress and admission to the neonatal care unit. Customised birth weight or ultrasound EFW charts that are adjusted for important independent physiological variables, such as maternal weight, maternal height, ethnic group and parity, have better sensitivities for identifying SGA foetuses and identifying morphometric evidence of FGR, have lower false-positive rates, and are predictive of poor perinatal events. Serial measurements of AC and EFW (growth velocities) are superior to single estimates of AC or EFW in the prediction of FGR (abnormal neonatal ponderal index and skinfold thickness) and predicting poor perinatal outcome. However, use of growth alone to diagnose growth restriction (especially when the interval between the scan is less than two weeks) can lead to high numbers of false positives. Reference charts of foetal biometry based on cross-sectional data are commonly used for assessing growth velocity. However, it is charts based on longitudinal growth studies that reflect growth correctly. Such charts are available from a well-designed study of a British population, and should be used for measuring growth velocity. Use of standard deviation scores, as opposed to simply “eyeballing” the growth pattern, is likely to result in a more reliable and accurate assessment of growth. 4C - 12 Module 4C 4C - 13 A systematic review in the Cochrane Database of Systematic Reviews has shown that routine ultrasounds after 24 weeks in low-risk pregnancies do not improve perinatal outcomes. An ultrasonic examination is one method to check for IUGR. During this examination a number of values are assessed. They include expected weight of the foetus and head and abdomen circumference. The most useful value is the expected weight of the foetus. This weight is determined from the values of the head circumference, abdominal circumference, and the length of the thigh. Abdominal circumference and expected weight of the fetus are the most reliable values to diagnose IUGR. In high risk groups sensitivity of this measure is 72.9–94.5% and specificity is 50.6–83.8%. The measure is more effective if dynamics are tracked and customized growth charts are used. The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Vandenbosche RC, Kirchner JTR. Intrauterine growth retardation. Am Fam Physician. 1998 Oct 15;58(6):1384-90 Chang TC, Robson SC, Boys RJ, Spencer JA. Prediction of the small for gestational age infant: which ultrasonic measurement is best? Obstet Gynecol. 1992 80(6):1030-8. Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks of gestation) (Cochrane Review). Cochrane Database Syst. Rev. 2006 Slide 4C-21 Biophysical Tests to Diagnose IUGR All biophysical tests, including amniotic fluid volume (AFV), doppler, cardiotocography and biophysical scoring, are poor at diagnosing a small or growth- restricted foetus. The diagnostic accuracies of AFV and uterine artery doppler are given below as examples of limited accuracy of biophysical tests in diagnosing SGA/FGR. Despite the positive association between AFV and neonatal morphometry, the likelihood ratios remain low. For an amniotic fluid index (AFI), a positive test result has a likelihood ratio (LR) of 2.4 for predicting skinfold thickness below the tenth percentile, and an LR of 1.2 for predicting neonatal ponderal index below the 25th percentile. The respective negative LRs are 0.6 and 0.8. Serial measurements of AFI have similarly disappointing results. A systematic review published in 2000 found that uterine artery doppler had limited accuracy in predicting FGR and perinatal death. In low-risk populations the pooled LR to predict FGR was 3.6 for a positive test and 0.8 for a negative test. Even in the high-risk population the pooled LRs were 2.7 and 0.7 for positive and negative tests, respectively. Although various Doppler studies of foetal circulation, such as the aortic to middle cerebral artery pulsatility index ratio, are used to predict FGR foetuses, their use should be evaluated further in primary and secondary studies. A distinction should be made between biometric tests (i.e. tests to measure size) and biophysical tests (i.e. tests to assess fetal well-being). Biometric tests are designed to predict Effective Perinatal Care (EPC) size and if performed longitudinally growth but not well-being. Biophysical tests, on the other hand, are not designed to predict size but fetal well-being. Diagnostics normally assess one or more parameters of an acute condition weekly or, more often, twice a week, to identify potential postnatal viability of the foetus. Amniotic fluid is assessed once a week, but if its level decreases, more frequent examinations are necessary. In critical cases, foetal biophysical profile and non-stress test may be prescribed daily or even more often. If doppler tests are not available, a foetal biophysical profile can be used as a primary method of observing a foetus with IUGR. Ferrazzi E, Bellotti M, Vegni C, Barbera A, Della Peruta S, Ferro B, et al Umbilical flow waveforms versus fetal biophysical profile in hypertensive pregnancies.Eur J Obstet Gynecol Reprod Biol 1989;33: The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Slide 4C-22 Tests Used in ANC for Surveillance of Suspected SGA Slide lists tests used for assessment of surveillance of suspected SGA (taken from reference below). The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Slide 4C-23 Antenatal Cardiotocography (Non-Stress Test) The use of cardiotocography (CTG) to assess fetal condition before birth is not associated with an improved perinatal outcome; in fact, a systematic review of randomised trials showed that there was a trend towards increased mortality in the group receiving CTG compared with those who did not (insert citation). Computer systems for interpreting CTGs are more accurate than clinical experts in predicting umbilical acidosis and depressed Apgar scores (insert citation). However, further evaluation of this technology is required 4C - 14 Module 4C 4C - 15 before clinical recommendations can be made regarding its widespread use. The technology of cardiotocography was developed in the1950s and appeared on the market in the 1960s. In the 1960s theories about cardiotocography were developed based on limited experimental and empirical evidence. These theories encouraged the use of this method, and many hospitals purchased cardiotocography monitors for their delivery rooms (at first in limited quantities, and later to allow monitoring of all women about to deliver). Initially clinicians expected that cardiotocography (CTG) would help to solve two issues: 1) to serve as a screening test for severe asphyxia at birth (severe enough to cause neurological consequences or death of the foetus), and 2) to recognize early signs of metabolic acidosis, which would enable obstetricians to prevent brain damage induced by asphyxia, or death of the newborn. The concept of using prenatal or intrapartum CTG to predict the status of the newborn caught hold in obstetrical practice, and was rapidly followed by expanded use of CTG. At the time that CTG monitoring was introduced, almost all intranatal deaths and cerebral paralysis were thought to be related to intrapartum asphyxia. Newer data show that only 10% of cerebral paralysis cases are caused by intrapartum asphyxia. The majority of cases of cerebral paralysis appear to be caused by developmental defects, migration defects, infections, toxins, anterpartum ischemic or asphyxia episodes in the foetus, or other factors. Unfortunately, the incidence of cerebral paralysis did not reduce with the introduction of CTG monitoring. Advantages of the no-stress test include: inexpensive, easy to use, no contraindications. Disadvantages of the no-stress test include: diagnoses hypoxia / acidosis too late, must be repeated twice a week for women in high risk groups, marks only acute hypoxia – provides limited information about chronic foetoplacental deficiency, is not reliable on small terms, 85% will have a reactive no-stress test between 28 and 32 weeks. The analysis of the four largest clinical trials does not provide any basis for the use of antenatal no-stress CTG as an additional method to assess the status of the foetus if there is no indication of high risk. In addition, there was no evidence of a significant impact on: C-Section rates; low Apgar score; pathologic neurological disorders in the newborn; or hospitalizations in the NICU. However, perinatal mortality increased 3 times. Parer JT, King T. Fetal heart rate monitoring: is it salvageable? Am J Obstet Gynecol. 2000 Apr;182(4):982-7 The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Slide 4C-24 Biophysical Profile of the Foetus The foetal biophysical profile is a score resulting from a test conducted over a 30– minute period. The test assesses foetal activity by monitoring foetal movements, breathing motions, tone and volume of the amniotic fluid, and the presence of accelerations on cardiotocography. Decreased volume of amniotic fluid is an indirect marker of decreased glomerular filtration, due to cardiac output bypass from foetal kidney in response to chronic hypoxia. The foetal biophysical profile is tested by Effective Perinatal Care (EPC) an ultrasound in ȼ-regime in real time. A score of 0 (absence) or 2 (presence) is granted to each of the 4 observed variables described in Table III. The maximum score possible is 8 without a non-stress test or 10 with a non-stress test. A management plan is created based on the test score. Re-assessments of patients with inconclusive scores (6 out of 10, normal volume of fluid) will be conclusive in 75% of cases. If results remain inconclusive or poor, delivery should be based on foetus-related indications (II-3B). A modified foetal biophysical profile assesses only 2 parameters: accelerations in the cardiotocographic trace and the amount of amniotic liquid. If the average pocket size of the amniotic cavity is less than 2 cm, the biophysical profile identifies it as a sign of oligohydramios. Two other techniques are commonly used: 1) Maximum depth of a vertical pocket: According to this method, 2-8 cm pocket depth is identified as normal, 1-2 cm as boundary, < 1 cm as reduced, and > 8 cm as increased; or 2: Amniotic fluid index: This helps to quantitatively assess the total amount of amniotic fluid by adding the deepest vertical pockets of liquid in the four quadrants of the uterus, the centre being in the navel. This method uses the 5th and 95th percentiles for gestational age to identify oligohydramnios and hydramnios, accordingly. A recent cohort study identified a significant decrease of cerebral paralysis from 4.74/1000 in the group of unexamined women of “low risk” to 1.33/1000 in the group of examined women of “high risk” (II-3B). Patients with a score of 8 out of 10 or 6 out of 10 (abnormal volume of amniotic fluid) were indicated extraction of a term foetus. For a pre-term foetus under 34 weeks of gestation, intensive observation to increase maturity as much as possible is preferable (III-C). Robert Liston,Vancouver BC, Joan Crane, Foetal health surveillance in labour., SOGC Clinical Practice Guidelines. No. 112, April 2002 Slide 4C-25 Doppler Velocimetry of Umbilical Artery A systematic review with a meta-analysis has provided compelling evidence that the use of umbilical artery Doppler to monitor high-risk foetuses reduces perinatal morbidity and mortality. In addition, there was a significant reduction in the number of antenatal admissions and inductions of labour associated with Doppler use. A study comparing foetal heart-rate monitoring, biophysical profile and umbilical artery Doppler found that only umbilical artery Doppler had value in predicting poor perinatal outcomes in SGA foetuses. Use of Doppler does not lead to increased 4C - 16 Module 4C 4C - 17 interventions as the rates of positive test are low (2.7% of all umbilical artery tests in high-risk women). There is evidence that the use of Doppler ultrasound to manage SGA foetuses reduces the use of resources compared with cardiotocography. Screening a low-risk or unselected population by umbilical artery Doppler does not reduce perinatal mortality or morbidity. Umbilical artery Doppler is not recommended for screening this population. Umbilical artery Doppler should be used as the primary surveillance tool. . Doppler velocimetry of the umbilical artery should not be used as a screening method for the entire population. Today a Doppler test of the umbilical blood flow seems to be important for pregnancies complicated with IUGR or accompanied by hypertension / pre-eclampsia. This test may be useful in other pregnancies of high risk; however, more study is needed to identify the specific groups of patients. The most frequently used method of analyzing umbilical flow waveforms is the systolic-diastolic ratio (S/D). However, the presence of systolic blood flow has more clinical significance than the absolute value of the S/D ratio. Null and reverse umbilical blood flows signify critical disturbances of foetoplacental blood flow, with subsequent antenatal death in 3-7 days. Interventions based on identification of abnormal umbilical flow waveform allow a reduction in perinatal mortality by 38% in pregnancies at risk (confidence interval 15-55%) (I-A). It has been shown that it is safe to repeat Doppler velocimetry every two weeks. Fetal Health Surveillance In Labour. SOGC Clinical Practice Guidelines NO. 112 2002 The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Slide 4C-26 Surveillance of a Suspected Small Foetus during Pregnancy When an anomaly scan and umbilical artery Doppler are normal, the small foetus is likely to be a ‘normal small foetus’. Evidence suggests that outpatient management of such foetuses is safe. Additionally, a randomised controlled trial of two regimens of foetal surveillance for SGA foetuses with normal umbilical artery Doppler found that twice-weekly compared with fortnightly monitoring resulted in earlier deliveries and more inductions of labour with no difference in neonatal morbidity. This suggests that frequency of monitoring in SGA foetuses with normal Doppler need not generally be more than once every fortnight. The frequency of antenatal examinations must be in line with presumptive risk of asphyxia and their practical value for the patient. For example, for a patient who notes a temporary reduction Effective Perinatal Care (EPC) in foetal movements, one standard assessment is enough. After confirming that the foetus is normal, if there are no other risk factors the patient can go back to regular prenatal care. The frequency of antenatal examinations should reflect the level of risk. In cases where the observed risk continues, examinations should be once or twice a week (II-3ȼ). However, there may be a need for daily or even more frequent antenatal examinations to identify the time of delivery to increase the gestational age as much as possible, avoiding significant morbidity in pre-term foetuses (III-C) (e.g. in cases of severe pre-eclampsia). The investigation and management of the small for gestational age fetus. Royal College of Obstetricians and Gynaecologists. November 2002 Fetal Health Surveillance In Labour SOGC Clinical Practice Guidelines NO. 112. 2002 Slide 4C-27 The Only Effective Management of IUGR In cases of severe IUGR and severe foetal impairment, emergency delivery is the preferred method. In cases of IUGR in a compensated stage, periodic assessment of foetal well-being is required. The aim of assessment is early identification of the development of conditions threatening the life of the foetus. For these conditions an emergency pre-term delivery is the best choice to maintain the life of the foetus and prevent morbidity, rather than prolonging the pregnancy when being in-uteri becomes increasingly dangerous. 4C - 18 Module 4C 4C - 19 Slide 4C-28 Assessment of Foetal Well- Being Intrapartum This slide explains the aim of intrapartum assessment of foetal well-being Fetal Health Surveillance In Labour SOGC Clinical Practice Guidelines NO. 112..2002 Slide 4C-29 Continuous Foetal Heart Rate Monitoring during Labour Indications for continuous electronic foetal heart beat monitoring include: Maternal problems: x Previous caesarean section x Pre-eclampsia x Post-term pregnancy (> 42 weeks) x Prolonged membrane rupture (> 24 hours) x Induced labour x Diabetes x Antepartum haemorrhage x Other maternal medical disease Foetal problems: x Foetal growth restriction x Prematurity x Oligohydramnios x Abnormal Doppler artery velocimetry x Multiple pregnancies x Meconium-stained liquor x Breech Intrapartum conditions: x Oxytocin augmentation x Epidural analgesia x Vaginal bleeding in labour x Maternal pyrexia x Fresh meconium- stained liquor For continuous foetal monitoring all healthcare providers must know the pace of the paper used for each individual case to avoid misinterpretation. Precise times should be noted on the electronic monitoring records. Electronic monitoring records must be checked and documented every 15 minutes in the active stage of labour and at least every 5 minutes in the second stage of labour (III-C). The time of foetal electronic monitoring patterns should be identified in combination with uterus contractions. Frequency, duration, and intensity of contractions, as well as the tone in resting Effective Perinatal Care (EPC) condition, should be assessed and recorded. Abdomen palpation, tocodynamometer or an intrauterine pressure catheter may be used to facilitate assessment (III-C). Practitioners should use standard terminology to describe the characteristics of foetal heartbeat rate in the foetal electronic monitoring records (III-C). Blood sampling from the foetal cephalic vein is recommended if there are any electronic monitoring patterns that cannot be interpreted or cause concern, such as persistent minimum or absent variability, irremovable late decelerations, advancing foetal tachycardia or abnormal FHR characteristics in auscultation (II-3B). There are limited data available on the use of labour admission tests to justify further studies to identify the utility of such screening approaches (III-C). The Use of Electronic Fetal Monitoring - The use and interpretation of cardiotocography in intrapartum fetal surveillance. Evidence-based Clinical Guideline Number 8. RCOG Royal College of Obstetricians and Gynaecologists. 2001 Fetal Health Surveillance In Labour. SOGC Clinical Practice Guidelines NO. 112. 2002 Slide 4C-30 Categories of Foetal Heart Rate 4C - 20 Module 4C 4C - 21 The Use of Electronic Fetal Monitoring - The use and interpretation of cardiotocography in intrapartum fetal surveillance. Evidence-based Clinical Guideline Number 8. RCOG Royal College of Obstetricians and Gynaecologists. 2001 Slide 4C-31 In Case of Suspicious CTG: When the CTG is suspicious, conservative measures should be used. When the CTG falls into the pathological category, conservative measures should be used and foetal blood should be sampled where appropriate/feasible. When foetal blood sampling is not possible or appropriate, delivery should be expedited. The Use of Electronic Fetal Monitoring - The use and interpretation of cardiotocography in intrapartum fetal surveillance. Evidence-based Clinical Guideline Number 8. RCOG Royal College of Obstetricians and Gynaecologists. 2001 Slide 4C-32 “Foetal Distress” and “Foetal Hypoxia” The Committee on Obstetric Practice is concerned about continued use of the term “foetal distress” as an antepartum or intrapartum diagnosis and the term “birth asphyxia” as a neonatal diagnosis. The Committee reaffirms that the term “foetal distress” is imprecise and non- specific. The communication between clinicians caring for women and those caring for neonates is best served by replacing the term “foetal distress” with “nonreassuring foetal status”, followed by a further description of findings (e.g., repetitive variable decelerations, foetal tachycardia or bradycardia, late decelerations, or a low biophysical profile). The term has a low positive predictive value even in high-risk populations and often is associated with an infant who is in good condition at birth as determined by the Apgar score or umbilical cord blood gas analysis or both. In the past the term “foetal distress” generally referred to an ill foetus: currently the term “nonreassuring foetal status” describes a clinician’s interpretation of data regarding foetal status (i.e., the clinician is not reassured by the findings). This acknowledges the imprecision inherent in the interpretation of the data. Therefore, the diagnosis of “nonreassuring foetal status” can be consistent with the delivery of a vigorous neonate. Foetoplacental deficiency identified by ultrasonic examination is one of the main reasons for hospitalizing women in departments of pregnancy pathology in post-Soviet countries. Effective Perinatal Care (EPC) “Foetoplacental deficiency” is not a disease; this is a pathological physiological process. “Newborn hypoxia” is not a clinical condition, it is a metabolic process (metabolic acidemia) that can be confirmed by blood gas analysis. Intrauterine growth retardation is one of the key conditions indicating possible hypoxia and fetoplacental deficiency. IUGR is the most objective marker of decompensated foetoplacental deficiency. One definition of foetoplacental deficiency: A pathological state when the ability of the placenta to maintain adequate metabolism between the mother and the foetus decreases, thus impairing metabolic, trophic, endocrinal, transportation, barrier, and gas exchange functions of the placenta and the foetus. Hypoxemia is associated with a decrease in blood saturation with oxygen. Hypoxia is associated with the decrease of cell and tissue saturation with oxygen. Anoxia is extremely low saturation of cells with oxygen, leading to death. Foetoplacental system adaptation in response to hypoxemia is associated with an increase of oxygen capture effectiveness and maintenance of aerobic glycolysis in all tissues. Its clinical signs are a decrease in foetal movements and a start of growth delay. Foetuses can live in such conditions for several days to several weeks, but cannot survive in these conditions for months. As hypoxia appears, stress hormones start to excrete and blood flow is reallocated; metabolism in peripheral tissues becomes anaerobic. This is clinically presented by foetal growth retardation. Foetuses can live in hypoxia up to several days. In cases of extremely low oxygen saturation (almost no oxygen - anoxia), blood flow is completely reallocated in all organs and tissue, including the brain; metabolism becomes anaerobic. Its clinical signs are cardiac failure, followed by death. Codes in International Classification of Diseases (10th revision): Class XVI. SOME CONDITIONS OF THE PERINATAL PERIOD (Ɋ00- Ɋ95) Ɋ03. Stunted growth and malnutrition of the foetus Savel'eva GM, Chekhonin VP, Pavlova TA, Kushch IB, Shalina RI, Rogatkin SO, Morozov SG, Volodin NN An immunochemical analysis of the function of the hemato-encephalic barrier in acute fetal hypoxia and asphyxia neonatorum. Akush Ginekol (Mosk). 1991 Feb;(2):43-6. (Article in Russian) Inappropriate use of the terms fetal distress and birth asphyxia. ACOG (American College of Obstetricians and Gynecologists Committee on Obstetric) Practice. Committee Opinion #303: Obstet Gynecol. 2004; 104(4):903 Slide 4C-33 “Intrapartum Asphyxia” (1) All of these conditions must be present. If any of the conditions are lacking, one cannot conclude that hypoxic acidemia existed or had the potential to cause neurologic deficits. Fetal Health Surveillance In Labour. SOGC Clinical Practice Guidelines NO. 112. 2002 4C - 22 Module 4C 4C - 23 Slide 4C-34 “Intrapartum Asphyxia” (2) “Intrapartum Asphyxia” is a criterion “A Posteriori” Obstetricians can only suspect a “nonreassuring foetal status” on the basis of “nonreassuring or abnormal categories of FHR”. The most appropriate term for the determination of foetal well-being disorders is “nonreassuring foetal status”. Inappropriate use of the terms fetal distress and birth asphyxia. . ACOG( American College of Obstetricians and Gynecologists) Committee on Obstetric Practice Opinion #303: Obstet Gynecol. 2004; 104(4):903 Slide 4C-35 Standard Observation of Foetus during Delivery 1. Women in active labour should receive continuous close support from an appropriately trained professional. One-on-one nursing is recommended (I-A). 2. Intermittent auscultation following an established protocol of surveillance and response is the preferred method of foetal surveillance in healthy pregnancies during the active phase of labour (I-A). 3. Labour induction requires close monitoring of uterine activity and foetal heart rate (III-B). 4. If intermittent auscultation detects an abnormal foetal heart rate and the foetus is unresponsive to resuscitative measures, surveillance should be increased with continuous electronic fetal monitoring or fetal scalp sampling, or delivery should be induced (I-A). 5. Continuous intrapartum electronic foetal monitoring is recommended: a) For pregnancies where there is an increased risk of perinatal death, cerebral palsy, or neonatal encephalopathy (III-C). b) When oxytocin is being used for augmentation of labour (1-A). c) When oxytocin is being used for induction of labour (III-C). 6. For continuous electronic foetal monitoring all health professionals involved must know the paper speed used in each case to avoid misinterpretation. The correct time should be recorded on the electronic foetal monitoring record (III-C). 7. Electronic foetal monitoring records should be inspected and documented every 15 minutes during the active phase of labour and at least every 5 minutes during the second stage of labour (III-C). Effective Perinatal Care (EPC) 8. The timing of electronic foetal monitoring patterns should be determined in association with uterine contractions. The contraction frequency, duration, intensity, and resting tone should be assessed and documented. Abdominal palpation, a tocodynamometer, or an intrauterine pressure catheter may be used to facilitate the assessment (III-C). 9. Practitioners should use standard terminology when describing foetal heart rate characteristics of an electronic foetal monitoring record (III-C). 10. Foetal scalp blood sampling is recommended when electronic foetal monitoring patterns are uninterpretable or not encouraging, such as sustained minimal or absent variability, uncorrectable late decelerations, increasing foetal tachycardia, and abnormal FHR characteristics on auscultation (II-3B). 11. Further research is required to establish the utility of labour admission tests as a screening approach (III-C). Fetal Health Surveillance In Labour. SOGC (Society of Obstetricians and Gynecologists of Canada) Clinical Practice Guidelines NO. 112. 2002 Robert Liston, MB, FRSC., Vancouver BC Joan Crane, MD, FRCSC, St John’s NF SOGC (Society of Obstetricians and Gynecologists of Canada) clinical practice directives # 112, April 2002 Slide 4C-36 Conclusions: This slide summarizes basic recommendations for managing women with IUGR. 4C - 24 Module 5ɋ Management of Normal Labour and Birth Effective Perinatal Care (EPC) 5C - 2 Module 5C Slide 5ɋ-1 Management of Normal Labour and Birth Learning Objectives: x To question any activity performed in labour without clear justification x To recognize the importance of providing comprehensive support to the woman and family in childbirth x To be familiar with the WHO recommendations on labour and birth management x To be able to offer non- pharmacological pain relief and different positions for labouring women Slide 5ɋ-2 Background The last several years brought along a change in attitude towards medical care in labour and birth. The results of a randomized controlled trial, that showed the adverse effects of many interventions in birth (for example, routine pubic shaving, enema, episiotomy, artificial rupture of foetal membranes, unjustified labour induction), as well as the WHO Recommendations prompted a change in attitude and obstetric practices. In the recent years, health professionals began to consider the woman’s feelings and obstetrics became more humane. Some routine interventions in labour and delivery are no longer considered beneficial or necessary. Interventions are performed only if indicated, which occurs less often than health professionals would believe necessary. Such advancement in maternity care resulted in growing focus on the woman and her needs in childbirth, as well as the use of “the policy of non-intervention” in delivery. Care in normal birth: A practical guide. Report of a technical working group. WHO, 1997. Beverley Chalmers et al., Women's Experiences of Birth in St. Petersburg, Russian Federation, Following a Maternal and Child Health Intervention Program, Birth, 1998, 25 (2), 107–116. 5C - 3 Effective Perinatal Care (EPC) Slide 5ɋ-3 Women’s Experiences of Birth: What Women Remember as Unpleasant Despite decrease of incidence of complications during pregnancy and childbirth, many women remained unsatisfied with the quality of care. At the same time well conducted research showed that many inventions routinely practiced during labour and delivery (most of them being painful, embarrassing, humiliating, and disrespectful) are not only ineffective, but may do more harm than good. In the past, a substantial proportion of what was done during childbirth was not evaluated for effectiveness. Surveys of women’s experience with birth revealed a high proportion of dissatisfaction with offered care. There were different reasons for dissatisfaction: routine or inappropriate use of some technologies (delivery in birthing chairs, painful vaginal examination); not respecting dignity; restrictions that are not rational and useful (prohibiting visiting women and babies, prohibiting use of home clothes). Women were unhappy with the fact that very often maternity care has no human face. Beverley Chalmers et al., Women's Experiences of Birth in St. Petersburg, Russian Federation, Following a Maternal and Child Health Intervention Program, Birth, 1998, 25 (2), 107–116. Slide 5ɋ-4 Adherence to Outdated Practices Description of birth experience in former Soviet Union countries: Many times women appear physically battered after birth, with extremely painful perineums resulting from deep and extensive episiotomies, which preclude sitting for some days or even weeks, combined with bruising from excessive manual stretching of the perineum during second stage of labour, and with extensive bruising of their arms from intravenous lines. Pale and sore they lie unmoving for hours after birth, alone, in dilapidated old bed caved in with overuse… Chalmers B, Levin A. Humane Perinatal Care. Tea publishers, Tallinn, Estonia, 2001. 5C - 4 Module 5C Slide 5ɋ-5 Key factors of Women’s Satisfaction with Birth (1) A woman's dissatisfaction with the experience of labour and birth may affect her emotional well being and willingness to have another baby. The aim of the one randomized controlled study was to investigate the prevalence and risk factors of a negative birth experience in a national sample. The following risk factors were found: (1) factors related to unexpected medical problems, such as emergency operative delivery, induction, augmentation of labour, and infant transfer to neonatal care; (2) factors related to the woman's social life, such as unwanted pregnancy and lack of support from partner; (3) factors related to the woman's feelings during labour, such as pain and lack of control; and (4) factors that may be easier to influence by the caregivers, such as insufficient time allocated to the woman's own questions at antenatal checkups, lack of support during labour, and administration of obstetric analgesia. Many risk factors were related to unexpected medical problems and participants' social background. Of the established methods to improve women's birth experience, childbirth education and obstetric analgesia seemed to be less effective, whereas support in labor and listening to the woman's own issues may be underestimated Waldenstrom U, Nilsson CA. Women's satisfaction with birth center care: a randomized controlled study. Birth, 2004, 20(1), 3-13. Waldenström U et al. A Negative Birth Experience: Prevalence and Risk Factors in a National Sample. Birth, 1993, Volume 31, Issue 1, Page 17. Slide 5ɋ-6 Key factors of Women’s Satisfaction with Birth (2) The patient’s values include unique preferences, concerns and expectations of each patient visiting the doctor which must be considered in making clinical decisions. Hodnett ED. Pain and women's satisfaction with the experience of childbirth. A systematic review. Am J Obstet Gynecol 2002 (suppl);186: S160- 172. 5C - 5 Effective Perinatal Care (EPC) Slide 5ɋ-7 The WHO Recommendations for Birth Over 20 years ago, a Conference in Fortaleza, Brazil, made a number of recommendations about appropriate practices during childbirth and proposed to discontinue those whose effectiveness was not supported by evidence, and do not respect a clients dignity and psychological needs. These recommendations are still valid and implemented by many health systems. In 1985, WHO’s Regional Office for Europe and the Regional Office for the Americas held a joint conference that was attended by over 60 participants from North and South America and Europe, representing midwives, obstetricians, paediatricians, health administrators, sociologists, psychologists, economists and clients. The Conference made a number of recommendations based on the principle that each woman has a fundamental right to receive proper prenatal care; that the woman has a central role in all aspects of this care, including participation in the planning, carrying out and evaluation of the care; and that social, emotional and psychological factors are decisive in the understanding and implementation of proper prenatal care. Joint Interregional Conference on Appropriate Technology for Birth Fortaleza, Brazil, 22 - 26 April . WHO EURO, PAHO, 1985. Consensus Conference on Appropriate Technology Following Birth. Trieste, Italy, 7-11 October. WHO EURO, 1986. Slide 5ɋ-8 Shaving (1) Pre-delivery shaving was advocated in the belief that it decreases the risk of maternal and foetal infection and makes suture of perineal tears safer and easier. These assumptions were challenged by two randomized trials. These trials were unable to detect any effects of pubic shaving on incidence of puerperal infections. The trials showed a higher bacterial colonization of the skin in shaved women. Randomized trials evaluating preoperative shaving in surgical patients also found no benefits of this procedure. Basevi V, Lavender T. Routine perineal shaving on admission in labour. The Cochrane Database of Systematic Reviews, 2007, Issue 1. 5C - 6 Module 5C Slide 5ɋ-9 Shaving (2) Because usefulness of pubic shaving has not been proven by researches and is associated by many adverse effects, in early 1980’s it was proposed to discontinue this procedure. In many countries pubic shaving was abandoned, however others countries still continue to use it. There are many disadvantages of pubic shaving: abrasions of the skin, risk of hepatitis and HIV transmission, discomfort during hair growth, women’s embarrassment during procedure. Basevi V, Lavender T. Routine perineal shaving on admission in labour. The Cochrane Database of Systematic Reviews, 2007, Issue 1. Slide 5ɋ-10 Enema (1) Enema is another procedure that has been discontinued in many countries. It was suggested more than 20 years ago that routine use of this procedure was not justified. It was believed that enema stimulates uterine contractions, allowing the presenting part to descend and shorten the duration of labour. Another presumed benefit was reduced contamination at delivery and lower risk of maternal and foetal infections. Two randomized, controlled trials determined no positive effect of enema on duration of labour, no decrease in the rate of neonatal infection or number of perineal wound infections. Without the enema faecal soiling was mainly slight and easier to remove than after the enema. Mahan CS, McKay S. Routines: Preps and Enemas – Keep or Discard? Contemporary OB-GYN, November, 1983, 22, 241-248. 5C - 7 Effective Perinatal Care (EPC) Slide 5ɋ-11 Enema (2) This practice is not without risks and is considered by most women to be unpleasant. The practice is uncomfortable and associated with rare but serious complications, such as rectal irritations, colitis, gangrene, and anaphylactic shock. Half of the women expressed negative feeling about receiving an enema such as embarrassment, discomfort, or reluctance. Most women who did not receive an enema were pleased or relieved. Cuervo LG, Rodríguez MN, Delgado MB. Enemas during labour. The Cochrane Database of Systematic Reviews, 2007, Issue 1. Slide 5ɋ-12 Individual Labour and Birth Room (1) A photo of an individual labour and birth room. Slide 5ɋ-13 Individual Labour and Birth Room (2) A photo of an individual labour and birth room 5C - 8 Module 5C Slide 5ɋ-14 Delivery Room Ensuring privacy, confidentiality and partner support are possible only in an individual birth room. The use of an individual birth room also prevents cross-infection. When the woman goes into labour, she is admitted to the same room where the baby will be born – no need for a pre- delivery room. Birth room should be clean, but not sterile. After each delivery, the bed and the floor are washed with soap or any other appropriate detergent. Birth room should be warm without any draughts. Life-saving equipment and drugs for mother and baby must be available in each birth room. The birth room must have a very good light to make newborn observation convenient. The birth room should be family-oriented, with a possibility for companion presence during labour and birth. There must be chairs for relatives. The birth room environment should be as home-like as possible and ensure the woman’s comfort (curtains, posters or wall decoration, music, plastic flowers, etc.) Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO, Geneva, 1996. Slide 5ɋ-15 Equipment Necessary for Each Delivery Room Every item of basic equipment must be in delivery room by the birth of the baby. In 50% of case resuscitation cannot be predicted. A clean heated table or a table with a radiant heater is a prerequisite for warm newborn resuscitation, if necessary. 2 newborn size masks – one for a low birth weight baby, the other – for a normal weight baby. If a baby cap is not available, it can be replaced by a warm towel. A clock with a seconds hand is needed to note the time of birth and the start of newborn resuscitation, if it is necessary. Availability of a mercury thermometer with points below 35ɨɋ or an electronic thermometer is necessary to diagnose and timely treat newborn hypothermia. 5C - 9 Effective Perinatal Care (EPC) Some of the listed equipment items may be kept outside of the delivery room but not far away, (for instance, an incubator or a heated cradle). A newborn should not be transported along a cold corridor in the arms of a healthcare staff. Newborn transportation must be warm (a warm chain link) which will be explained in the next module. Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO, Geneva, 1996. Slide 5ɋ-16 Safe Delivery A safe delivery is one where the birth attendant monitors progress to avoid prolonged labour and to detect obstructed labour which can lead to haemorrhage, infection and shock in the mother and birth asphyxia and brain damage in the infant. WHO defines a safe delivery as one that is clean and carried out by someone having the necessary skills. A birth does not necessarily have to take place in hospital for it to be safe. Birth at home is accepted and encouraged in many parts of the world, both developed and developing, and may be quite safe for a woman provided she has skilled attendance during pregnancy and labour and access to emergency medical care if needed. Many alternatives to both home and hospital birth have developed in recent years, including independent birth centres, birth clinics, or home-like birthing rooms in hospital settings. All of these try to provide a less clinical environment for birth while simultaneously providing access to safe care. Common to them all is the need to provide a private place for a woman (with consideration for her wishes) during birth. Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO Geneva, 1996. Slide 5ɋ-17 Clean Delivery A clean delivery is one that is attended by health staff in a medical institution or by a trained birth attendant at home observing principles of cleanliness (clean hands, clean surface, clean cutting of the cord). All women and birth attendants should be aware of the requirements for a clean delivery: clean hands, clean delivery surface, clean cord cutting and care. All health care providers should be trained in and practice clean and safe delivery techniques and avoid unnecessary vaginal examinations and episiotomies. Routine internal examination should be kept to a minimum to ensure safe delivery from the medical view point, and such examinations should be carried out with the woman’s consent and involvement. Besides, appropriate sanitary conditions should be established. For example, 5C - 10 Module 5C women experiencing waters discharge or postpartum haemorrhage, should be offered sanitary towels. Soiling of bedding should be expected, and women should not feel uncomfortable if it happens. In many cases women are encouraged to bring along dressing gowns or other hygienic articles which they would like to use before, during or after birth. Also, the client’s privacy should be respected and strangers should not be allowed to be in the private areas of a maternity ward. The woman should not visit or walk around the common areas of the clinic/hospital during or after delivery. . Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO Geneva, 1996. Slide 5ɋ-18 Some Beneficial Interventions Maternal and perinatal care must have a holistic approach and meet physiological, emotional and psychological needs of mothers, newborns, fathers and the whole families. Pregnancy and birth are natural processes. To ensure their normal course, perinatal care must rest upon awareness, commitment, and involvement of the whole family and community. Women’s involvement in decision making, exercising initiative and in popularization should be encouraged by joint efforts calling attention to the issues of healthcare and health education worldwide. Workshop on perinatal care: report on a WHO expert meeting, Venice, Italy, 16–18 April. WHO EURO, 1998. Slide 5ɋ-19 Informing Women Women should be encouraged to participate in the decisions about her labour and birth to the extent in which it is possible and safe. 5C - 11 Effective Perinatal Care (EPC) Slide 5ɋ-20 Maternal Mortality in Selected Countries, 1919-1920 The majority of all birth, approximately 85%, can be considered normal, and only the remaining 15% require some specialized obstetric care. Therefore, as the primary attendant, recently midwives have received more authority. The importance of good midwifery training to enable them to effectively recognize the early signs of threatening complications became most evident in the recent years. Midwives all over the world have become recognized as the primary attendant in pregnancy and birth. With the same intra- and postpartum rates, the rate of interventions at birth in hospitals where deliveries were attended by doctors was much higher than in hospitals where deliveries were attended by midwives. The rate of labour induction and stimulation in low risk deliveries was twice higher, the episiotomy rate was15 times higher, and the rate of amniotomy and epidurals was 13 times higher. The rate of forceps deliveries doubled in deliveries attended by doctors versus deliveries attended by midwives, the rate of vacuum-extraction was 8.5 times higher. Caesarean sections were performed in 19% of cases in doctor attended group, versus 3.7% of those attended by a midwife. Marland H & A. M. Rafferty. “The midwife as health missionary: the reform of Dutch childbirth practices in the early twentieth century”. Midwives, Society and Childbirth, Debates and controversies in the modern period, Routledge, London, 1997, 153-179. Kenneth C Johnson and Betty-Anne Daviss. Outcomes of planned home births with certified professional midwives: large prospective study in North America. BMJ, 2005, 330, 1416. Slide 5ɋ-21 Presence of a Supportive Companion (1) One of the most effective components of midwifery-led care is continuous one to one support of the woman. This intervention has no SIDE EFFECTS or RISKS. It is necessary to understand the consequences of unsympathetic care for women in childbirth and support developing positive emotions in the woman and her family. Women should never be left alone during childbirth. Ideally, each birth is attended by a midwife. During labour, birth and early postpartum, the midwife provides physical, emotional and psychological support and care, encourages the presence of a companion, monitors the mother and fetal status, facilitates the physiologic process and minimizes technological interventions, involves the woman in decision making, identifies and resolves 5C - 12 Module 5C complications as they arise, responds appropriately to life-threatening emergencies and obtains appropriate back-up referral care for the mother and baby. The woman’s experience of birth are associated with her personal relations with the health professional attending birth. This component of maternal care is so important that some developed countries included recommendations about presence of one birth attendant throughout the birth in national guidelines (for example, Canada). As the study showed, companion (other than midwife) support during labour and birth has a very positive effect on labour advancement, its outcome, mother’s adaptation in postpartum period, mother and baby relationship and the couple’s adjustment. Impressive improvement of the woman is noted, along with significant shortening of labour, decrease in the number of Caesarean sections, decrease in the use of pain-relief drugs and the need for newborn emergency care. Women whose births were assisted by a companion, found it easier to establish breastfeeding, increased harmony between the couple, and increase in the infant’s wellbeing. Hodnett, E. D.; Gates, S.; Hofmeyr, G. J.; Sakala, C. Continuous support for women during childbirth. The Cochrane Database of Systematic Reviews, 2004, Issue 1. International Confederation of Midwives. Midwifery competencies, April, 2002 www.internationalmidwives.org/index World Health Report, 2005, Chapter 4 Slide 5ɋ-22 Presence of a Supportive Companion (2) Taking into account the positive effect of such intervention, many medical associations promote partner deliveries as the key element of improving maternal and infant health. Thus, partner presence at birth should not only be allowed but actively encouraged. Sometimes the ideal partner would be the woman’s husband or partner; in other situations another woman will be preferred. This could be the woman’s mother or the mother-in-law, her sister, friend or sometimes just the woman proposed by the maternity with whom the woman in childbirth has never met before (doula). In any case, it is the woman choice to select a partner as her companion for labour and birth. Evidence suggests that encouraging the woman to give birth with a partner or two whom she selects has more positive effect on the birth outcome than the majority of frequently used interventions which are often evaluated as useless by quality research. WHO advocates partner companions as the key component of care focusing on improving maternal and infant health. Hodnett, E. D.; Gates, S.; Hofmeyr, G. J.; Sakala, C. Continuous support for women during childbirth. The Cochrane Database of Systematic Reviews, 2004, Issue 1. 5C - 13 Effective Perinatal Care (EPC) Slide 5ɋ-23 Companion Presence and Support in Labour and Birth Childbirth is a very special event bringing long-time satisfaction to the woman and those who share this event with her. Slide 5ɋ-24 Food and Drink Restriction in Labour In many countries food and liquid consumption in labour is restricted due to the risk of stomach content aspiration (Mendelson’s syndrome) if the need for endotracheal narcosis arose. Evidence shows that food restriction in delivery does not guarantee prevention of this syndrome. Some studies on different pharmacological methods of changing the acidity of the gastric juices or food restriction in labour did not determine 100% protection by any of the drugs used. The range of PH values was quite broad and according to the researchers, mandatory prophylaxis antacid consumption did not prevent the syndrome. Labour is very energy-consuming. As duration of birth cannot be predicted, there needs to be continuous replenishment of energy. Enforced fasting may lead to poor progress of labour, the diagnosis of dystocia, and a cascade of interventions cumulating in a caesarean delivery. A study of woman in America who had had elevated ketones in labour reported that hunger was the most unpleasant sensations during labour. Abrupt restriction of nutrition in labour leads to dehydration and acidosis which can be prevented by consuming liquids and light food in delivery. Women in childbirth instinctively restrict themselves in excessive food intake, normally limiting themselves to drinking, cookies or chocolate. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. 5C - 14 Module 5C Slide 5ɋ-25 Maternal Positions in the First Stage of Labour The results of several studies suggest that the supine position can adversely affect both the condition of the foetus and the progression of labour, by interference with the uterine blood supply and by compromising the efficiency of uterine contractions. Frequent changes of maternal position may be a way of avoiding the adverse effects of supine recumbence. Women who were asked to stand, walk, or sit upright during labour had shorter labours than women who were asked to lie flat. Women also used less analgesics or epidurals, and received fewer oxytocics for augmentation of labour. One trial reported significantly lower incidences of foetal heart-rate abnormalities and depressed Apgar scores in women who adopted upright positions. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. Slide 5ɋ-26 Positions in the First Stage of Labour (1) If the woman prefers lying on her back during first stage of labour, REMEMBER to turn her on her left side to prevent the supine hypotension syndrome. This is when the heavy uterus reduces the blood return from the lower part of the body, reducing the input to the heart by compressing the inferior vena cava. As a result the output from the heart is also reduced, leading to falls in the pulse rate and blood pressure. This has a very detrimental effect on the blood supply to the uterus and reduces the amount of oxygen to the foetus. Slide 5ɋ-27 Positions in the First Stage of Labour (2) The woman should be free to move around freely, choosing comfortable positions – standing, walking, sitting, kneeling or squatting. Being active during labour is instinctive. It is also more comfortable, safer and more efficient, and it allows the mother to cope with her pain better. 5C - 15 Effective Perinatal Care (EPC) Slide 5ɋ-28 Positions in the First Stage of Labour (3) The mother may also like to lie in a warm bath, if available. This will relieve the discomfort as well as help her relax. Water as a means of relaxation during labour is growing in popularity. Slide 5ɋ-29 Free Choice of Position in the First Stage of Labour This photo demonstrates how to help the woman find a comfortable position in the first stage of labour. Slide 5ɋ-30 Maternal Positions in the First Stage of Labour This photo demonstrates how to help the woman find a comfortable position in the first stage of labour. 5C - 16 Module 5C Slide 5ɋ-31 Non-Pharmacological Methods of Pain Relief The degree of pain perceived by a woman in childbirth depends on her emotional state and cultural expectations. Her pain is less when she feels relaxed, unafraid, and reassured by the continuous, comforting support of her companion and/or birth attendant. Non-pharmacological methods of pain relief may help many women to cope with the pain without any risk of side effects or complications associated with analgesia and anesthesia. These techniques are not so effective as epidural analgesia or other pharmacological methods, but they seem to help some woman and are not likely to have harmful side-effects. Alternative methods of pain relief, particularly non-pharmacological ones, are preferable first- line approaches to pain management in labour. These include encouraging the woman to be ambulant in labour, to adopt different positions which bring relief even if only for a while, and to remain upright for as long as possible. Relaxation techniques, visual imagery which “takes the mother away” for a few moments, distraction and massage may all assist at times during labour and are preferable to pharmacological relief. Of great importance is emotional support and encouragement as well as praise for the woman for how well she is coping with the considerable pain of labour. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. Slide 5ɋ-32 Touch and Massage An example of a relaxation technique (touch and massage) 5C - 17 Effective Perinatal Care (EPC) Slide 5ɋ-33 Counter Pressure An example of a relaxation technique (counter pressure) Slide 5ɋ-34 Routine Cardiotocography (CTG) in the First Stage of Labour (1) Twelve trials were included (over 37,000 women); only two were of high quality. Compared to intermittent auscultation, continuous cardiotocography showed no significant difference in overall perinatal death rate (relative risk (RR) 0.85, 95% confidence interval (CI) 0.59 to 1.23, n = 33,513, 11 trials), but was associated with a halving of neonatal seizures (RR 0.50, 95% CI 0.31 to 0.80, n = 32,386, nine trials) although no significant difference was detected in cerebral palsy (RR 1.74, 95% CI 0.97 to 3.11, n = 13,252, two trials). There was a significant increase in caesarean sections associated with continuous cardiotocography (RR 1.66, 95% CI 1.30 to 2.13, n =18,761, 10 trials). Women were also more likely to have an instrumental vaginal birth (RR 1.16, 95% CI 1.01 to 1.32, n = 18,151, nine trials). Data for subgroups of low-risk, high-risk, preterm pregnancies and high quality trials were consistent with overall results. Access to fetal blood sampling did not appear to influence the difference in neonatal seizures nor any other prespecified outcome. Continuous electronic foetal heart rate monitoring should be offered and recommended for high- risk pregnancies where there is an increased risk of perinatal death, cerebral palsy or neonatal encephalopathy. Continuous electronic foetal heart rate monitoring should be used where oxytocin is being used for induction or augmentation of labour. Thacker SB, Stroup D, Chang M. Continuous electronic heart rate monitoring for fetal assessment during labour. The Cochrane Database of Systematic Reviews, 2002, Issue 1. Royal College of Obstetricians and Gynaecologists. The use of electronic foetal monitoring. Evidence-based Clinical Guideline. RCOG Press, 2001, Number 8. 5C - 18 Module 5C Slide 5ɋ-35 Routine Cardiotocography in the First Stage of Labour (2) 8 580 women admitted to the delivery ward of a Dublin teaching hospital who were at low risk of fetal distress in labour were randomly assigned admission cardiotocography (20 min) or the unit's usual care (intermittent auscultation only, with continuous cardiotocography only if clinically indicated). The primary outcome was moderate to severe neonatal morbidity, or perinatal mortality in the absence of a major congenital malformation. Analyses were by intention to treat. 44 (1.0%) women assigned admission cardiotocography did not undergo the procedure; 15 (0.4%) assigned usual care had admission cardiotocography. The primary endpoint occurred in 56 (1.3%) of 4298 women assigned admission cardiotocography and 55 (1.3%) of 4282 in the usual-care group (relative risk 1.01; 95% CI 0.70-1.47). Other indices of neonatal morbidity also showed no differences. Despite an increase in use of continuous cardiotocography (1.39; 1.33- 1.45) and foetal blood sampling (1.30; 1.14-1.47) with admission cardiotocography, there were no significant differences in the rates of caesarean delivery (1.13; 0.92-1.40), instrumental delivery (1.03; 0.92-1.16), or episiotomy (1.06; 0.99-1.13). Routine use of cardiotocography for 20 min on admission to the delivery ward does not improve neonatal outcome. No significant increase in operative delivery was apparent, probably because of liberal use of foetal blood sampling. L. Impey, M. Reynolds, K. MacQuillan, S. Gates, J. Murphy, O. Sheil. Admission cardiotocography: a randomised controlled trial. The Lancet, 2003, Volume 361, Issue 9356, Pages 465-470. Slide 5ɋ-36 Upright Versus Lithotomy Position in the Second Stage of Labour Delivering the baby in recumbent position was a routine in ex-Soviet Union countries. Many women found it awkward or uncomfortable. This practice can only be justified if there is good evidence that it is advantageous for mother and/or baby. Many studies showed that forcing women to lie flat is not justified and upright positions should be encouraged. Results should be interpreted with caution as the methodological quality of the 20 included trials (6135 participants) was variable. Use of any upright or lateral position, compared with supine or lithotomy positions, was associated with: reduced duration of second stage of labour (9 trials: mean 4.28 minutes, 95% confidence interval (CI) 2.93 to 5.63 minutes) - this was largely due to a considerable reduction in women allocated to the use of the birth cushion; a small reduction in assisted deliveries (19 trials: relative risk (RR) 0.80, 95% CI 0.69 to 0.92); a reduction in episiotomies (12 trials: RR 0.83, 95% CI 0.75 to 0.92); an increase in second degree perineal tears (11 trials: RR 1.23, 95% CI 1.09 to 1.39); increased estimated blood loss 5C - 19 Effective Perinatal Care (EPC) greater than 500 ml (11 trials: RR 1.63, 95% CI 1.29 to 2.05); reduced reporting of severe pain during second stage of labour (1 trial: RR 0.73, 95% CI 0.60 to 0.90); fewer abnormal foetal heart rate patterns (1 trial: RR 0.31, 95% CI 0.08 to 0.98). . Gupta JK, Hofmeyr GJ, Smyth R. Position in the second stage of labour for women without epidural anaesthesia. The Cochrane Database of Systematic Reviews, 2007, Issue 1. Slide 5ɋ-37 Upright Positions in the Second Stage of Labour Upright positions, compared with supine or lithotomy positions, was associated with an increase in second degree perineal tears (11 trials: RR 1.23, 95% CI 1.09 to 1.39); increased estimated blood loss greater than 500 ml (11 trials: RR 1.68, 95% CI 1.32 to 2.15). Note that one of the most important advantages of vertical positions is much lower incidence of abnormal foetal heart rate patterns. Although some births attendance reported some inconvenience with upright positions, women are very satisfied with them. The tentative findings of this review suggest several possible benefits for upright posture, with the possibility of increased risk of blood loss greater than 500 ml. Women should be encouraged to give birth in the position they find most comfortable. Until such time as the benefits and risks of various delivery positions are estimated with greater certain, women should be allowed to make informed choices about the birth positions in which they might wish to assume for delivery of their babies. Gupta JK, Hofmeyr GJ, Smyth R. Position in the second stage of labour for women without epidural anaesthesia. The Cochrane Database of Systematic Reviews, 2007, Issue 1. Slide 5ɋ-38 Positions in the Second Stage of Labour (1) Flat-lying positions that work against gravity and may cause foetal heart abnormalities should be avoided. The supine delivery position, traditionally used during this century in many maternity systems, is the least beneficial position to adopt for labour and delivery. If it is used even so, the woman’s legs should not be placed in stirrups as this is a most undignified position for a woman to adopt for delivery. If the legs need support, this is better provided by personal touch or by resting her feet on the bed than by using stirrups 5C - 20 Module 5C Slide 5ɋ-39 Positions in the Second Stage of Labour (2) The mother should be allowed to adopt whatever position is most comfortable, although she should be discouraged from lying on her back as this could cause supine hypotension syndrome. Mothers may feel more comfortable in a vertical upright position, which will also assist the descent of the foetus. Standing, sitting, kneeling or squatting positions are used by many mothers in the second stage of labour. The assistance of a partner is required in some cases to give support. Slide 5ɋ-40 Choosing a Comfortable Position in the Second Stage of Labour (1) An example demonstrating how to help the woman to choose a comfortable position in the second stage of labour Slide 5ɋ-41 Choosing a Comfortable Position in the Second Stage of Labour (2) An example demonstrating how to help the woman to choose a comfortable position in the second stage of labour 5C - 21 Effective Perinatal Care (EPC) Slide 5ɋ-42 Management of the Second Stage of Labour There is no evidence that a policy of early bearing down has any compensating advantages for either the mother or the baby. Active pushing early in the second stage is associated with increased frequency of abnormalities of the foetal heart rate and difficult or traumatic instrumental deliveries. So, a passive/non-pushing approach is preferred in the passive phase of the second stage (from fully dilated cervix until women feels the urge to push) provided the state of mother and foetus is monitored and not compromised. Second stage of labour x Vaginal assessment to confirm the cervix is fully dilated is the ONLY accurate means of diagnosis x Phase 1 (passive) from the time the cervix is fully dilated, until the presenting part descends to the pelvic floor. x Phase 2 (active) from the end of phase 1 to birth. x Duration: Historical arbitrary limits, which may be inappropriate, have been (A) Nulliparae: 2 hours and (B) Multiparae: 1 hour. x There is therefore no absolute limit or correct length for the second stage. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. Slide 5ɋ-43 Second Stage of Labour: Forms of Care Unlikely to be Beneficial These practices and recumbent position are factors that may increase risk of foetal distress, but not duration of the second stage. Recent approaches tend to regard time limits of second stage as guidelines only and not rigid boundaries indicative of a need for intervention. The status of the mother and infant is a better indicator of whether intervention is needed to assist at this point than simply the length of time that has passed. Flexibility in the management of the second stage of labour, including upright position, adequate analgesia, and delayed pushing if the woman does not have the urge to push, can reduce the need for operative vaginal birth. One multicentred randomized study demonstrated that women with epidurals were likely to have fewer operative interventions if they did not push in the second stage of labour until they had a strong urge to push or until 2 hours had passed. Flexibility with regard to time limits for 5C - 22 Module 5C the second stage of labour is also important. The rate of operative vaginal birth is reduced if the arbitrary time limit of 2 hours in the second stage of labour is abandoned when progress is being made. Royal College of Obstetricians and Gynaecologists (RCOG). Operative vaginal delivery. London (UK): RCOG Press, 2005, Guideline no. 26. Society of Obstetricians and Gynaecologists of Canada (SOGC). Guidelines for operative vaginal birth. Clinical practice guideline No 148, J Obstet Gynaecol Can, August 2004, 26, 747-53. Slide 5ɋ-44 Duration of the Second Stage of Labour Results of studies conducted during last 30 years support assumption that labour should not be terminated or augmented simply because an arbitrary period of time has elapsed in the second stage. In one RCT an obstetric data from 4403 nulliparas were analyzed in order to determine whether the duration of the second stage of labour influences perinatal outcome or maternal puerperal morbidity. No significant increase in the frequency of perinatal mortality, neonatal mortality, or low 5-minute Apgar scores was noted with long second stages. An increase in the incidence of low 1-minute Apgar scores was observed only in those infants who were not monitored. An increase in puerperal haemorrhage after more than 3 hours of second stage labour was attributable to those patients delivered by midforceps operations. It appears that it is unwarranted to terminate labour simply because an arbitrary period of time has elapsed in the second stage. Another RCT was conducted in order to investigate the relation between the duration of the second stage of labour and subsequent early neonatal and maternal morbidity. The analysis was confined to the 25,069 women delivered of an infant of at least 37 weeks gestation with a cephalic presentation following the spontaneous onset of labour. The duration of the second stage of labour had a significant independent association with the risk of both PPH and maternal infection after adjustment for other factors. However, there was a similar or greater risk of PPH in association with operative delivery or a birthweight greater than 4000 g. Both maternal pyrexia in labour and primiparity were associated with a greater risk of post partum maternal infection than was the duration of the second stage, although all these factors were statistically significant. In contrast, the duration of the second stage was not significantly associated with the risk of a low Apgar score or admission to SCBU after adjustment for other factors. The duration of the second stage of labour has a positive independent association with early maternal morbidity. We could show no such relation between time spent in the second stage of labour and the frequency of low Apgar scores or the rate of admission to Special Care Baby Unit. For a long time the second stage of labour has been thought of as a time of particular asphyxial risk for the foetus. This perceived risk has been invoked to justify arbitrary time limits and high 5C - 23 Effective Perinatal Care (EPC) rates of operative vaginal delivery. The purpose of one more RCT was to determine whether perinatal outcome worsened as the second stage lengthened. Over a 5-year period at one university teaching hospital, 6041 nulliparous women reached the second stage of labour with a live singleton cephalic fetus with birth weight > or = 2500 gm. A retrospective review of perinatal morbidity and mortality was performed and the results related to the duration of the second stage. The second stage lasted > 3 hours in 11% of nulliparous women and > 5 hours in 2.7%. There were no perinatal death unrelated to anomaly. There was no significant relationship between second stage duration and low 5-minute Apgar score, neonatal seizures, or admission to the neonatal intensive care unit. Operative intervention in the second stage is not warranted merely because some set number of hours has elapsed. Cohen WR. Influence of the duration of second stage labor on perinatal outcome and puerperal morbidity. Obstet Gynecol, 1977, 49(3), 266-9. Menticoglou SM et al. Perinatal outcome in relation to second-stage duration. Am J Obstet Gynecol. 1995, 173(3 Pt 1), 906-12. Saunders NS et al. Neonatal and maternal morbidity in relation to the length of the second stage of labour. Br J Obstet Gynaecol. 1992, 99(5), 381-5. Slide 5ɋ-45 Directed Pushing Remember that directed pushing has only one advantage (a shorter second stage of labour) while the disadvantages are clinically more significant. Directed pushing, together with breath holding, may affect foetal wellbeing. The mother will usually have an overwhelming desire to push with each contraction. It is much better to allow her to push naturally than to instruct her to take a deep breath and push down (which has been found to reduce oxygen supply to the foetus). Once crowning of the head has taken place the mother is instructed to pant or puff, allowing the head to advance slowly, minimizing the risk of damage to the head and maternal birth canal. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. 5C - 24 Module 5C Slide 5ɋ-46 Delayed Pushing The objective of this study was to compare obstetrical outcomes associated with coached versus uncoached pushing during the second stage of labor. Study design: Upon reaching the second stage, previously consented nulliparous women with uncomplicated labors and without epidural analgesia were randomly assigned to coached (n = 163) versus uncoached (n = 157) pushing. Women allocated to coaching received standardized closed glottis pushing instructions by certified nurse-midwives with proper ventilation encouraged between contractions. These midwives also attended those women assigned to no coaching to ensure that any expulsive efforts were involuntary. Results: The second stage of labor was abbreviated by approximately 13 minutes in coached women (P = .01). There were no other clinically significant immediate maternal or neonatal outcomes between the 2 groups. Conclusion: Although associated with a slightly shorter second stage, coached maternal pushing confers no other advantages and withholding such coaching is not harmful. Bloom Steven L.; Casey Brian M.; Schaffer Joseph I.; Mcintire Donald D.; Leveno Kenneth J. Coached versus uncoached maternal pushing during the second stage of labour: a randomized controlled trial. Obstet Gynecol. 2002, 99(6), 1031-5. Leah L. Albers, Kay D. Sedler; Edward J. Bedric, Dusty Teaf, Patricia Peralta. Midwifery Care Measures in the Second Stage of Labor and Reduction of Genital Tract Trauma at Birth: A Randomized Trial. Journal of Midwifery & Women's Health, 2005, 51(5), 365-372. Slide 5ɋ-47 Perineal Care (1) A randomized controlled trial evaluated benefits of guarding the perineum. The results of this trial show that more women in the 'hands poised' group reported pain compared with 'hands on' group 910 (34.1%) versus 823 (31.1%) (RR 1.10, 95% CI 1.01 to 1.18). NNT=33. The rate of episiotomy was significantly lower in the 'hands poised' group (RR 0.79, 99% CI 0.65 to 0.96, P = 0.008). The rate of manual removal of placenta was significantly higher (RR 1.69, 99% CI 1.02 to 2.78; P = 0.008). There were no other statistically significant differences detected between the two methods. McCandlish R, Bowler U, van Asten H et al. A randomised controlled trial of care of the perineum during second stage of normal labour. Br J Obstet Gynaecol, 1998, 105(12), 1262-72. 5C - 25 Effective Perinatal Care (EPC) Slide 5ɋ-48 Perineal Care (2) Actually, guarding the perineum has very few advantages to the “hands poised” approach; the use of this procedure should not interfere with adoption of a free position. McCandlish R, Bowler U, van Asten H et al. A randomised controlled trial of care of the perineum during second stage of normal labour. Br J Obstet Gynaecol, 1998, 105(12), 1262-72. Slide 5ɋ-49 Episiotomy for Vaginal Birth (1) Six studies were included. In the routine episiotomy group, 72.7% (1752/2409) of women had episiotomies, while the rate in the restrictive episiotomy group was 27.6% (673/2441). Compared with routine use, restrictive episiotomy involved less posterior perineal trauma (relative risk 0.88, 95% confidence interval 0.84 to 0.92), less suturing (relative risk 0.74, 95% confidence interval 0.71 to 0.77) and fewer healing complications (relative risk 0.69, 95% confidence interval 0.56 to 0.85). Restrictive episiotomy was associated with more anterior perineal trauma (relative risk 1.79, 95% 1.55 to 2.07). There was no difference in severe vaginal or perineal trauma (relative risk 1.11, 95% confidence interval 0.83 to 1.50); dyspareunia (relative risk 1.02, 95% confidence interval 0.90 to 1.16); urinary incontinence (relative risk 0.98, 95% confidence interval 0.79 to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline episiotomy were similar to the overall comparison. Restrictive episiotomy policies appear to have a number of benefits compared to routine episiotomy policies. There is less posterior perineal trauma, less suturing and fewer complications, no difference for most pain measures and severe vaginal or perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive episiotomy. Median episiotomies are associated with higher risk of extension into the rectum and compromise of the external anal sphincter muscle, and mediolateral episiotomies are associated with greater postpartum pain, more blood loss, greater difficulty in repair, and more dyspareunia, especially when compared with spontaneous tears. Because of the potential for greater expansion of the pelvic floor with mediolateral episiotomy, this procedure may theoretically help lower the risk for incontinence. Carolli G, Belizan J, Stamp G. Episiotomy for vaginal birth. Cochrane Database of Systematic Reviews, 2003, Issue 4. 5C - 26 Module 5C Slide 5ɋ-50 Episiotomy for Vaginal Birth (2) There was no difference between restrictive and liberal (routine) use of episiotomy on severe vaginal or perineal trauma (relative risk 1.11, 95% confidence interval 0.83 to 1.50); dyspareunia (relative risk 1.02, 95% confidence interval 0.90 to 1.16); urinary incontinence (relative risk 0.98, 95% confidence interval 0.79 to 1.20) or several pain measures. Episiotomy is no longer regarded as a routine procedure for even primiparous birth. Current research indicates that this procedure should be performed only when medically indicated and quite possibly in less than 10% of deliveries. Analgesia should always be used when performing an episiotomy. Carolli G, Belizan J, Stamp G. Episiotomy for vaginal birth. Cochrane Database of Systematic Reviews, 2003, Issue 4. Slide 5ɋ-51 Physiological (Expectant) Management of the Third Stage of Labour Expectant management involves watchful waiting with no use of prophylactic drugs, cord traction, or fundal pressure. Expectant management of the third stage of labour involves allowing the placenta to deliver spontaneously or aiding by gravity or nipple stimulation. Management of the Third Stage of Labour in the Absence of Uterotonic Drugs: In some settings there will be no uterotonics available due to interruptions of supplies or the setting of birth. In the absence of current evidence, ICM and FIGO recommend that when no uterotonic drugs are available to either the skilled or non-skilled birth attendant, management of the third stage of labour includes the following components: x Waiting for signs of separation of the placenta (cord lengthening, small blood loss, uterus firm and globular on palpation at the umbilicus) x Encouraging maternal effort to bear down with contractions and, if necessary, to encourage an upright position x Controlled cord traction is not recommended in the absence of uterotonic drugs, or prior to signs of separation of the placenta, as this can cause partial placental separation, a ruptured cord, excessive bleeding and uterine inversion x Uterine massage after the delivery of the placenta as appropriate Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. Prendiville WJ et al. Active versus expectant management in the third stage of labour. 5C - 27 Effective Perinatal Care (EPC) The Cochrane Database of Systematic Reviews, Issue 3, 2000. International Confederation of Midwives (ICM) and International Federation of Gynaecology and Obstetrics (FIGO). Prevention and Treatment of Post-partum Haemorrhage: New Advances for Low Resource Settings. Joint Statement. 2006. Slide 5ɋ-52 Active Management of the Third Stage of Labour Data support the use of Active Management of the Third Stage of Labour (AMTSL) by all skilled birth attendants regardless of where they practice. AMTSL reduces the incidence of PPH, the quantity of blood loss and the use of blood transfusion, and thus should be included in any programme of interventions aimed at reducing deaths from PPH. The usual components of AMTSL include: x Administration of oxytocin or another uterotonic drug within one minute after the birth of the baby x Controlled cord traction x Uterine massage after delivery of the placenta as appropriate. International Confederation of Midwives, International Federation of Gynaecology and Obstetrics. Joint statement management of the third stage of labour to prevent post-partum haemorrhage. The Hague: ICM, London, FIGO, 2003. Slide 5ɋ-53 How to Perform Controlled Cord Traction (1) “Because of the benefits to the baby, the cord should not be clamped earlier than is necessary for applying cord traction in the active management of the third stage of labour. For sake of clarity, it is estimated that this will normally take around 3 minutes.” pg 16* “Current evidence shows that delayed cord clamping is beneficial for the baby. Therefore, delayed cord clamping must be recommended as a component of active management. Though there is controversy regarding the time at which the cord should be clamped, the panel agreed that by the time the baby is dried and wrapped and passed to the mother to breastfeed, the placenta usually separates and it is time to apply cord traction. The cord may therefore be clamped at that time.” pg 18* How to perform controlled cord traction: Clamp the cord close to the perineum (once pulsation stops in a healthy newborn) and hold in one hand. 5C - 28 Module 5C Place the other hand just above the woman’s pubic bone and stabilize the uterus by applying counter-pressure during controlled cord traction. Keep slight tension on the cord and await a strong uterine contraction (2-3 minutes). International Confederation of Midwives, International Federation of Gynaecology and Obstetrics. Joint statement management of the third stage of labour to prevent post-partum haemorrhage. The Hague: ICM, London, FIGO, 2003. *WHO recommendations for the prevention of postpartum haemorrhage WHO/MPS/07.06, 2007 Slide 5ɋ-54 How to Perform Controlled Cord Traction (2) With the strong uterine contraction, encourage the mother to push and very gently pull downward on the cord to deliver the placenta. Continue to apply counter-pressure to the uterus. If the placenta does not descend during 30-40 seconds of controlled cord traction do not continue to pull on the cord: x Gently hold the cord and wait until the uterus is well contracted again; x With the next contraction, repeat controlled cord traction with counter- pressure. Never apply cord traction (pull) without applying counter traction (push) above the pubic bone on a well-contracted uterus. As the placenta delivers, hold the placenta in two hands and gently turn it until the membranes are twisted. Slowly pull to complete the delivery. If the membranes tear, gently examine the upper vagina and cervix wearing sterile/disinfected gloves and use a sponge forceps to remove any pieces of membrane that are present. Look carefully at the placenta to be sure none of it is missing. If a portion of the maternal surface is missing or there are torn membranes with vessels, suspect retained placenta fragments and take appropriate action. International Confederation of Midwives, International Federation of Gynaecology and Obstetrics. Joint statement management of the third stage of labour to prevent post-partum haemorrhage. The Hague: ICM, London, FIGO, 2003. 5C - 29 Effective Perinatal Care (EPC) Slide 5ɋ-55 Advantages of Active Versus Expectant Management of the Third Stage of Labour Compared to expectant management, active management (in the setting of a maternity hospital) was associated with the following reduced risks: x Maternal blood loss (weighted mean difference -79.33 millilitres, 95% confidence interval -94.29 to -64.37) x Post partum haemorrhage of more than 500 millilitres (relative risk 0.38, 95% confidence interval 0.32 to 0.46) x Prolonged third stage of labour (weighted mean difference -9.77 minutes, 95% confidence interval -10.00 to -9.53) Prendiville WJ et al. Active versus expectant management in the third stage of labour. The Cochrane Database of Systematic Reviews, Issue 3, 2000. Slide 5ɋ-56 Active Versus Expectant Management Comparison of active or expectant management of the third stage of labour by some indicators. Prendiville WJ et al. Active versus expectant management in the third stage of labour. The Cochrane Database of Systematic Reviews, Issue 3, 2000. Slide 5ɋ-57 Active Management of the Third Stage of Labour Active management was associated with an increased risk of maternal nausea (relative risk 1.83, 95% confidence interval 1.51 to 2.23), vomiting (RR 2.19, 95% CI 1.68, 2.86), raised blood pressure (RR 3.46 95% CI 1.68, 7.09) (probably due to the use of ergometrine). No advantages or disadvantages were apparent for the baby. Prendiville WJ et al. Active versus expectant management in the third stage of labour. The Cochrane Database of Systematic Reviews, Issue 3, 2000. 5C - 30 Module 5C Slide 5ɋ-58 Interventions of Unproven Effectiveness It is not appropriate to place ice packs on the mother’s abdomen to assist this process since this is very uncomfortable for the mother and has not been shown to be effective in reducing haemorrhage. After delivery of the placenta the vagina and perineum are observed for any signs of excessive bleeding or damage during the delivery. Small tears to the perineum (other than major second and all third degree tears) have been found to heal better without sutures, but the perineum must be kept clean and therefore the need for personal hygiene must be stressed to the mother. It is not necessary to routinely check the cervix after birth for tears or to swab the vagina with any antiseptic solutions. Only if bleeding is not contained must small tears be sutured. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002. Slide 5ɋ-59 Management of the First Stage of Labour Many maternity hospitals have changed their attitude to delivery management. Now women’s feelings are considered, and birth management became is more humane during the recent years. The position to perform interventions in birth only when necessary and appropriate indications are seen, is becoming more popular.. An intervention is justified only if the status of the woman or foetus is a concern and indications for such intervention are available. Slide 5ɋ-60 Management of the Second Stage of Labour During the second stage of labour, the whole tempo and nature of activities surrounding labour tend to change. Although the principles of care throughout labour remain as a continuum, at this time woman often become more vulnerable and dependent on the influence of those who assist them. Discussion about alternatives and choices is not easy at this time, and this leaves the caregiver with even more than usual responsibility to safeguard the interests of the mother 5C - 31 Effective Perinatal Care (EPC) and baby. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. Slide 5ɋ-61 Management of the Third Stage of Labour If the woman has the right to choose, she will prefer active management of the third stage of labour. It should be remembered at all times that the first few minutes and hours of contact between a mother and her newborn baby (and her partner if he is present) are very special life moments. They will probably be remembered forever and make a lasting impression on the woman. Feelings evoked at this time may influence the relationship between the mother and baby for years to come. It is essential for the health care provider to remain sensitive to this impressionable period and to care for the family with support, encouragement and praise. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000. Slide 5ɋ-62 Inappropriate Routine Practices in Early Postpartum Period 5C - 32 Module 6ɋ Initial Rapid Assessment of the Newborn and Principles of Neonatal Care Effective Perinatal Care (EPC 6C - 2 Module 6C Slide 6ɋ-1 Initial Rapid Assessment of the Newborn and Principles of Neonatal Care At the end of the module participants will: x Know the main steps of newborn care immediately after birth x Understand the major adaptations experienced by newborns at birth x Know how to prepare a safe and warm room for each delivery x Know the list of needed equipment for newborn care x Know the universal precautions to prevent infection x Know how to implement the warm chain x Be able to assess the status of a newborn at birth and to take immediate action x Know the main principles of newborn care during the first two hours of life. Slide 6ɋ-2 How the Newborn Adapts to Extra-Uterine Life At birth the newborn must adapt quickly to the life outside of the uterus. x The baby will start to oxygenate his/her blood through spontaneous breathing x The newborn will adapt to extra-uterine life with changes in the cardiovascular system x The in utero temperature is 37-38°C where as the temperature in the delivery room is around 25°C. Therefore the newborn immediately has to start maintaining his/her own body temperature x The newborn will initiate feeding to provide him/herself with necessary calories x He/she will start interacting immediately with his/her mother/family. 6C - 3 Effective Perinatal Care (EPC Slide 6ɋ-3 Principles of Newborn Care Basic Steps (1) The main steps of newborn care at birth, which should be applied to all infants. Slide 6ɋ-4 Principles of Newborn Care Basic Steps (2) All of the steps of newborn care are aimed at ensuring adequate adaptation of the neonate after birth. Not following these steps will lead to the development of problems in the newborn. Slide 6ɋ-5 Universal Precautions According to WHO, 38% of neonatal deaths are caused by infection. Where hygiene is poor, the newborn could be infected. Therefore prevention of infection is essential for newborn care. Infection prevention practices help to prevent transmission of infection to or from the mother, baby, and medical staff. They also reduce the risk of passing hepatitis and HIV. Hand washing is the easiest and most effective way to prevent infection transmission. Hand washing needs to be done with soap and water followed by appropriate drying. Individual towels are important to prevent germ transmission and proliferation. Universal precautions must be applied to each patient. Each mother and baby must be considered as potentially infectious, thus you must protect the patient from infection in the maternity. You also must prevent staff from becoming infected. 6C - 4 Module 6C Medical staff should wear gloves when touching any biological fluids, e.g. with broken skin, mucous membranes, blood, or other body fluids such as amniotic fluid. Safe waste disposal is an important part of infection control in any health facility. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 Slide 6ɋ-6 Preparation for Birth Only individual labour and birth rooms ensure privacy, confidentiality and allow companion support. Individual birth rooms prevent cross- contamination and infection. At the start of labour, each woman should be admitted to the room where the baby will be born. There is no need to have pre-delivery rooms. The birth room must be clean but not sterile. After each birth the bed and floor should be cleaned with soap or any suitable detergent. The lighting should be sufficient to enable good observation of the baby. The labour and birth room should be family oriented, allowing and inviting companions to stay. Chairs for companions, water should be available in the birth The delivery room needs to be as home-like as possible, insuring a feeling of comfort (curtains, posters on the walls or decorations, music, plastic flowers etc). For each birth skilled health professionals must be available, especially a midwife. Mother-baby package: Implementing safe motherhood in countries. Department of Reproductive Health and Research, WHO, 1996 Slide 6ɋ-7 Equipment Required for Every Birth Basic medical equipment and drugs should be readily available in each delivery room. A wall clock with 2 hands is necessary to precisely assess the time of birth and the starting time of resuscitation if any. The room needs to be equipped as much as possible with basic equipment which enables the mother to select her delivery position (Ex: gym ball for relaxation, Swedish gym or equipment to allow the woman to hang, etc.). A clean table with a heater is mandatory to ensure warm resuscitation of the baby if necessary. Availability of a baby cap, socks, warm linens, blanket and a digital 6C - 5 Effective Perinatal Care (EPC thermometer or low reading thermometer (lower than 35°ɋ) for taking newborn body temperature is mandatory. Warm towels for drying the baby, warm linens in the absence of a baby’s cap (could replace the baby hat if it is not available), equipment for suction (catheter or bulb), set for cord clamping/cutting, essential drugs (for resuscitation, Vitamin K, eye ointment) and resuscitation equipment (bag and masks sized for a newborn) must be prepared in advance and be readily available for each delivery. Each piece of equipment needs to be in the delivery room before the birth. Some equipment may not be needed in each delivery room, but should be nearby (Ex: incubator or a heated cradle). Mother-baby package: Implementing safe motherhood in countries. Department of Reproductive Health and Research, WHO, 1996 Slide 6ɋ-8 Drying the Baby The different steps in newborn care support the newborn’s adaptations at birth. Drying the baby stimulates breathing and at the same time prevents heat loss, thus supporting thermal control. Drying the baby is the most intense sensory stimulation provoking spontaneous breathing at birth. Evaporative heat loss from the skin results in the lowering of skin temperature within seconds after birth. This heat loss is physiologic and impossible to avoid. If cooling continues in the minutes following birth however, the body temperature will drop below 36.5°C (the baby’s temperature can decrease by 2-4°C) and hypothermia will occur, leading to many complications. A baby born in a room at 23°C experiences the same cold stress as a naked adult exposed to 0°C. Thus immediate drying at birth is mandatory and is started as soon as the baby is born. x The midwife receives the baby in warm and dry linen and dries him/her carefully. The wet linen is then removed. x The midwife immediately puts the baby on the mother’s naked chest and continues to dry him/her carefully, focusing on the belly and head. The first wet towels need to be quickly replaced with dry and warm ones. The baby’s head should be covered with a small hat if available or with a piece of linen. The baby‘s feet should be covered with socks. Both mother and baby should be covered with a warm blanket and left skin-to-skin. Thermal Protection of the Newborn: A Practical Guide. WHO, Geneva, 1997 6C - 6 Module 6C Slide 6ɋ-9 Newborn Heat Loss The newborn baby loses heat in four different ways: x Evaporation - at birth the baby is wet and the moisture evaporates, which causes heat loss. x Conduction - if the baby is placed on a cold surface (such as a cold scale), she/he will lose heat through conduction between his/her body and the cold surface. x Radiation - the baby also loses heat via radiation from his body to cold objects, like a wall, even if the baby is not touching the object directly. x Convection - the baby also loses heat via convection if exposed to cold air or a draft. Thermal Protection of the Newborn: A Practical Guide. WHO, Geneva, 1997 Slide 6ɋ-10 What is Hypothermia? Newborn hypothermia is an important condition leading to many complications. It can be avoided by the correct implementation of the warm chain. Correct preparation of the delivery room (Slide 6) with needed equipment for the baby’s temperature control is critically important for hypothermia prevention. Thermal Protection of the Newborn: A Practical Guide. WHO, Geneva, 1997 Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 Slide 6ɋ-11 Hypothermia This drawing explains how hypothermia can harm a newborn. There is much evidence that hypothermia is harmful. Prolonged hypothermia will induce a vicious cycle: a hypothermic baby has decreased sucking ability and impaired feeding will lead to decreased heat production and worsening hypothermia. To maintain body temperature, the baby will use glucose which can lead to hypoglycaemia; severe hypoglycaemia can 6C - 7 Effective Perinatal Care (EPC lead to convulsions which can lead to brain damage. Along with increased glucose consumption, the baby will also use more oxygen, which can lead to respiratory distress. Hypoxia and hypoglycaemia can lead to acidosis. Hypothermia also increases the risk of bleeding disorders and the risk of infection. All of these conditions can be avoided by strict implementation of the warm chain to prevent heat loss. Slide 6ɋ-12 “Warm Chain” Means: This is the complete warm chain. It is named “warm chain” because if any link is missing, the baby will not be able to maintain its body temperature and will risk becoming hypothermic. All of the steps are interconnected and must be implemented to allow the newborn to initiate its own body temperature regulation. To implement effective warm chain, staff need to be trained and work as a team (obs/gyn, midwife, neonatologist, pediatric nurse and anesthesiologist). Poor implementation of the warm chain is not due to a lack of equipment, but to a lack of knowledge and poor team work. The warm chain needs to start before birth – the labour and birth room must be set at a temperature of no less than 25°C. If birth of a premature baby is expected, the temperature needs to be at least 28°C. The delivery room needs to be free of draught. After drying the baby is placed on the mother’s chest for skin-to-skin contact. Significant heat loss occurs through the baby’s head (the head constitutes 25% of the body surface). Thus the baby‘s head needs to be covered with a baby hat, but if that is not available the head could be covered by a piece of linen. The mother and baby should be covered with a warm blanket. The first breastfeeding should take place when the baby is ready. Usually breastfeeding will begin during the first hour of life and helps the baby’s thermo regulation by providing calories. After skin-to-skin contact, the baby needs to be appropriately dressed, not tightly swaddled, and stay with its mother in the same room (rooming-in). If the baby needs any kind of extra care including resuscitation, heat loss must be prevented using a heater. The newborn must be transported to the nursery under warm conditions (heated incubator, heated cradles or wrapped in a warm blanket if no other possibilities exist). Thermal Protection of the newborn: a practical guide. WHO, Geneva, 1997 6C - 8 Module 6C Slide 6ɋ-13 How to Dress the Baby Appropriately? Tight swaddling should be discouraged. If no baby hat is available, use a piece of dry linen. The newborn should be dressed like an adult but with one additional layer of clothes. Thermal Protection of the newborn: a practical guide. WHO, Geneva, 1997 Slide 6ɋ-14 The Harm of Tight Swaddling There is a common misconception that swaddled babies are protected against infection. However, there is no scientific evidence of this. Rather, Yurdakok and colleagues found pneumonia and acute respiratory disease occurs four times more often in tightly swaddled babies. It is preferable to wrap the baby loosely in a cotton cloth or in a warm shawl, or as a compromise, to swaddle only the lower part of the body, leaving the arms and head free to move. Yurdakok, K., et.al., 1990 Thermal Protection of the newborn: a practical guide. WHO, Geneva, 1997 Slide 6ɋ-15 Assess the Newborn’s Well-Being Drying the Baby, Assessing Well- Being and Making Decisions (for example: resuscitation) are done simultaneously while drying. As soon as the infant is born, while drying him/her, the health professional should immediately assess the infant’s well-being in order to identify if he/she needs special care or if he/she can be given immediately to the mother. Pregnancy, Childbirth, Postpartum and Newborn Care:A Guide for Essential Practice. WHO, Geneva, 2006 6C - 9 Effective Perinatal Care (EPC Slide 6ɋ-16 Components of the Assessment Normal/adequate breathing is initiated within 30 seconds after birth. Normal breathing rate is 30 – 60 breaths per minute, with no sign of respiratory distress such as chest indrawing, grunting, gasping. If the baby is crying he/she is breathing adequately, so there is no need to count the heartbeat rate. The heartbeat rate must be counted if meconium is present in the amniotic fluid. The rapid assessment must be done within 30 seconds to identify those newborns that need immediate resuscitation. The baby’s face and chest must be pink, not gray or blue after 1-3 minutes. A pink colour is a good sign of adequate breathing and circulation. It is important to ensure that the baby does not have a blue tongue and blue lips, which can indicate central cyanosis. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 American Heart Association in collaboration with International Liaison Committee on Resuscitation. Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 13: Neonatal Resuscitation Guidelines. Circulation, 2005, 112: 188 -195. European Resuscitation Council Guidelines for Resuscitation, 2005. Section 6: Paediatric Life Support. Slide 6ɋ-17 Classification and Management Four types of situations exist: x The most common: The baby is over 2,500 g and over 37 weeks gestation. She/he is crying and breathing well and his/her heart rate is over 100 beats per min. He/she is not suffering any significant malformation. The baby should be left on the mother’s chest, should ideally stay in skin-to-skin contact for two hours, and initiate breastfeeding. x The second situation: If the baby is not breathing well, bag and mask resuscitation must start as soon as possible. x The third situation: The baby is small, less than 2,500g or less than 37 weeks gestation. Low birth-weight newborns are at higher risk of having respiratory problems, and of becoming hypothermic and hypoglycaemic. They need special care. Nevertheless, except for very small babies less than 1,500g, many of them 6C - 10 Module 6C are not “sick“and should stay with their mothers under strict monitoring in the delivery room. The weight at birth is only estimated. A trained health professional does not need to weigh baby to recognize a LBW baby. Nevertheless, the majority of LBW babies should stay with their mothers. Only VLBW babies (less than 1,500g) require immediate special care. The gestational age is expressed in weeks and is normally known before birth. x The fourth situation: The baby has a significant malformation such as spina bifida or gastroschisis and requires immediate intervention. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 Managing Newborn Problems: A Guide for Doctors, Nurses, and Midwives. WHO, Geneva 2003. Slide 6ɋ-18 Cleaning the Airway Aspiration (sucking) from the mouth and the nose can cause apnoea and bradycardia. Do not rush – an adequately breathing baby doesn’t need any aspiration. Aspirate gently from the mouth and the nose of the newborn only if the amniotic fluid is stained with meconium or if the baby needs resuscitation. Randomized controlled trials show that there is no evidence that routine aspiration at the birth of the head with meconium-stained fluid decreases the rate of meconium- aspiration syndrome. The randomized controlled trial included 2,514 term babies with meconium-stained fluid: One group received aspiration from the mouth and the nose before the birth of the shoulders; the other group did not receive any aspiration. The rate of meconium-aspiration syndrome was the same in both groups. Oronasopharyngeal suction at birth: effects on arterial oxygen saturation. The effect of oronasopharyngeal suction (ONPS) on arterial oxygen saturation (SaO2) is described in a controlled study of 30 normal term newborn infants. In 15 of them, ONPS was performed immediately after birth. The SaO2 value was recorded through a pulse oximeter. The ONPS group had a significantly lower SaO2 between the first and the sixth minutes of life and took longer to reach 86% and 92% saturation. According to this study, ONPS should not be performed as a routine procedure in normal, term, vaginally-born infants. Furthermore, we need to pay attention to the results of this research because sometimes a therapy we perform with the best of intentions not only is unhelpful, but is actually harmful. Murray W. Enkin et al. A Guide to Effective Care in Pregnancy And Childbirth, Oxford, Third edition, 2000 Vain, E. Szyld, L. Prudent, T. Wiswell, A. Aguilar, N. Vivas Oropharyngeal and Nasopharyngeal Suctioning of Meconium-Stained Neonates Before Delivery of their Shoulders: Multicentre, Randomised Controlled Trial. The Lancet, Volume 364, Issue 9434, Pages 597-602. 6C - 11 Effective Perinatal Care (EPC Wiswell TE, Gannon CM, Jacob J., et al. Delivery room management of the apparently vigorous meconium-stained neonate. Paediatrics, 2000, 105:1-7 Slide 6ɋ-19 Early Skin-to-Skin Contact Like all of the previous steps, Step 6 aims to facilitate breastfeeding, thermal protection of the newborn, infection prevention, and mother-to- infant bonding. The newborn is able to: - see - establish eye contact with the mother in the first hours of life - feel (pain, cold, warmth) - smell (mother’s smell) - taste (special taste of mother’s milk) - cry (happily or unhappily) The baby needs to stay on the chest of the mother for at least two hours with no external interference. The mother’s chest needs to be naked, nipples easily accessible. The chest of the mother doesn’t need to be specially cleaned (no soap, no disinfectant, and no alcohol) The baby should be naked, well dried and with a covered head (hat, linen). Staying on the mother’s chest facilitates early initiation of breastfeeding. The baby will “crawl” to the breast. The mother and baby should be covered together with a warm blanket. The first few hours after birth is a special “sensitive” period, and this period is important to promote mother-to-baby bonding. Separation even for one or two days disturbs the bonding process and has a detrimental effect on the mother’s care of the baby and on breastfeeding. Restrict the duration of mother and baby separation. If separation is necessary (for example, if the baby is sick), frequent visits to the neonatal unit should be organized as soon as possible to enable the mother to start caring for her sick baby. It is extremely important to allow the mother, baby, and other family members (if present), to be together to initiate bonding. The mother needs to see her baby, to establish eye contact, and to touch her baby. In case of a Caesarean section in which regional anesthesia was used, the baby may be placed on the mother’s chest during the recovery. Early breastfeeding with skin- to-skin contact for 2 hours with the mother is preferable. If general anesthesia was used or if the mother is unstable, the baby should be put on the chest of the father and left for two hours in order to support thermal control, infection prevention and bonding. Only early breastfeeding cannot be implemented but it is recommended to bring the baby to the mother as soon as she is awake. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential 6C - 12 Module 6C Practice. WHO, Geneva, 2006 Andersson GC. et al. Early Skin-to-Skin Contact for Mother and their Healthy Newborn Infants. Review, Cochrane Library, issue 1, 2004 Slide 6ɋ-20 Skin-to-Skin Contact Photos of skin-to-skin contact between baby and mother (after vaginal birth). and between father and baby (after Caesarean section) Slide 6ɋ-21 Cord Clamping and Cutting It is not urgent to clamp the cord except in emergency situations, if the neonate needs resuscitation. Early cord clamping (immediately after birth) results in low haemoglobin values and may result in anaemia after 1 or 2 months. Late clamping results in hypervolemia and hyperviscosity of blood, which can lead to respiratory and cardiac problems. “Because of the benefits to the baby, the cord should not be clamped earlier than is necessary for applying cord traction in the active management of the third stage of labour. For sake of clarity, it is estimated that this will normally take around 3 minutes.” pg 16* The cord should be clamped in two places: first clamp or tie two fingers away from the baby‘s abdomen, then four fingers away from the baby’s abdomen. A randomized controlled trial compared early cord clamping with delayed cord clamping in newborns before 37 weeks of gestation. In the trial, the maximum delay in cord clamping was in 30-120 seconds after birth. Late cord clamping was associated with a decrease of transfusion due to newborn anaemia and due to the decrease of arterial blood pressure. Also, the number of intraventricular haemorrhages was less in the group with delayed cord clamping. Use elastic tying material as after one hour cord shrinkage loosens non-elastic bands and re-opens blood vessels, increasing the risk of both bleeding and infection. 6C - 13 Effective Perinatal Care (EPC In countries with limited resources, the most appropriate tying material is a rubber band applied around the cord with forceps. Plastic cord clamps are very useful, but expensive and not reusable. Narendra Aladangady et al. Infants’ Blood Volume in a Controlled Trial of Placental Transfusion at Preterm Delivery. Pediatrics, 2006, 117: 93-98. H Rabe, G Reynolds, J Diaz-Rossello Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database of Systematic Reviews, 2004, Issue 4. Camila M Chaparro et al. Effect of Timing of Umbilical Cord Clamping on Iron Status in Mexican Infants: A Randomised Controlled Trial. Lancet. June 2006; 367: 1997-2004 Jose´ M. Ceriani Cernadas et al. The Effect of Timing of Cord Clamping on Neonatal Venous Hematocrit Values and Clinical Outcome at Term: A Randomized, Controlled Trial. Pediatrics, 2006; 117: 779-786. WHO recommendations for the prevention of postpartum haemorrhage. WHO/MPS/07.06, 2007 Slide 6ɋ-22 Early Breastfeeding Breastfeeding helps to establish thermal protection of the newborn, infection prevention, and mother-to- infant bonding. The newborn is ready to feed 15 to 55 minutes after birth. Never force the baby to take the breast (don’t put the nipple into the baby’s mouth) before he/she is ready to feed. Wait for signs of readiness which include: • Baby looks at the mother’s breast. • Baby moves to the mother’s breast. • Baby touches the mother’s breast. • Baby shows searching/rooting reflex (his/her head and shoulders move, smacks his/her lips, opens his/her mouth). Early and unlimited breastfeeding gives the newborn energy to stay warm, nutrition to grow, antibodies to fight infection and reinforces bonding between mother and baby. Assist the mother to find a comfortable breastfeeding position when the baby shows signs of readiness for feeding. Assess the baby’s attachment to the breast, looking for the four signs. Praise the mother and assist her to attach the baby to the breast correctly, if needed. Do not limit breastfeeding: the baby will stop by himself/herself. Breastfeeding counselling: Training course. WHO, UNICEF, 1993 Slide 6ɋ-23 Early Breastfeeding 6C - 14 Module 6C Photo of a first breastfeeding within skin-to-skin contact and correct signs of attachment. Slide 6ɋ-24 Preventive Procedures Around 0.5% of newborns have a vitamin K deficiency at birth. Vitamin K is given to prevent early and later haemorrhagic disease. Preterm neonates are more vulnerable to a lack of vitamin K due to liver immaturity. They are thus more exposed to risk of gastrointestinal or other types of bleeding. They need to receive Vitamin K if it is available. Apply antibiotic ointment to prevent gonorrhoea conjunctivitis within one hour (but not later) after birth. Wait until after the mother and baby have established eye contact to administer eye treatment as the ointment will prevent the baby from seeing his/her mother. The use of 1% Silver nitrate is not recommended; it is effective, but may cause chemical conjunctivitis. Puckett RM, Offringa M. Prophylactic Vitamin K for Vitamin K Deficiency Bleeding in Neonates (Cochrane Review). The Cochrane Library, Issue 3, 2005 Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 Murray W. Enkin et al. A Guide to Effective Care in Pregnancy and Childbirth. Oxford, Third edition, 2000 6C - 15 Effective Perinatal Care (EPC Slide 6ɋ-25 Monitoring the Baby during the First Two Hours Even a healthy baby needs to be monitored carefully during the first two hours after birth: every 15 minutes for the first hour and every 30 minutes for the second hour. To assess the baby, staff do not need to interrupt skin-to-skin contact. The breathing rate can be counted by watching the baby’s back, grunting is easy to listen for and the colour should be checked on the face. The feet should be checked for warmth. This correlates with the baby’s warmth. If the baby’s feet are cold, take the baby’s temperature at that time. Axillary temperature can be taken while the baby is in skin-to-skin contact with the mother. Routinely measure the baby’s temperature 30 minutes and two hours after birth with a digital or low reading thermometer Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 Slide 6ɋ-26 How to Re-Warm the Baby? Before re-warming, remove the baby’s cold clothing. Dress the baby in a pre-warmed shirt open at the front, a diaper, hat and socks. Continue or immediately start skin-to- skin contact. Cover the mother and baby with an additional warm blanket. Check the body temperature every hour until the temperature is in the normal range (36,5-37,5 C). After that, assess warmth every 4 hours; check body temperature every 12 hours Continue breastfeeding to ensure the necessary calorie intake. If the baby’s temperature does not increase within two hour after all measures taken or decreases, additional methods of re-warming must be used: incubators, additional radiant heater, and heated cradles. If you put the baby into a device he must be dressed in warm, dry and loose clothes. Monitor the baby’s well-being: look for cyanosis, grunting, appearance of danger signs. Keep the temperature in the room no less than 25°ɋ. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 6C - 16 Module 6C Slide 6ɋ-27 Complete Assessment of the Newborn Conduct a complete examination of the baby after two hours of skin-to- skin contact. All information must be recorded in the newborn’s file, including the time of first attachment to the breast, first defecation and first urination. Pregnancy, Childbirth, Postpartum and Newborn Care: A Guide for Essential Practice. WHO, Geneva, 2006 Slide 6ɋ-28 Rooming-In Rooming-in: The arrangement (in a maternity unit) that allows the mother to be with her newborn at all times, without interruption. Rooming-in results in thermal protection, breastfeeding, infection prevention and bonding. The mother must take routine care of the baby and touch him/her; this will lead to the prevention of infection. Mother and baby should stay together from the moment of birth. This will establish contact between mother and baby. Rooming-in leads to exposure of the baby to the mother’s germs. The baby is kept warm and receives emotional support. It is very important that family members can help the mother in newborn care, especially after Caesarean section, when the mother does not feel well. Maternity staff should not replace the mother in newborn care. Staff can help, council, listen to the mother and answer her questions, but should not replace the mother. Tell the mother that she can take the baby into her own bed during feedings (if she feels comfortable). There is no risk of crushing or infecting the baby. Mother-baby package: Implementing safe motherhood in countries. Department of Reproductive Health and Research, WHO, 1996. Murray W. Enkin et al. A Guide to Effective Care in Pregnancy and Childbirth. Oxford, Third edition, 2000 6C - 17 Effective Perinatal Care (EPC Slide 6ɋ-29 Rooming-In Photos of rooming-in. Slide 6ɋ-30 Conclusions Key recommendations on mother and infant care: x Staff, labour and birth rooms and equipment must always be ready for every birth. x All health professionals involved in childbirth must know how to resuscitate a baby and how to prevent and/or treat hypothermia. x Timely assessment of the newborn’s status, skin-to-skin contact, early breastfeeding and rooming-in are key points in newborn care. x Do not leave the mother and baby unattended in the birth room. x Complete assessment of the baby should be postponed for two hours. x Weigh the baby, measure the baby’s length, and perform cord care during the complete assessment of the baby. 6C - 18 Module 6C Table 1. Check the Availability of the Following Equipment Table with heater Yes ( ) No ( ) Resuscitation equipment (bag, masks of two sizes) Yes ( ) No ( ) Oxygen source Yes ( ) No ( ) Aspiration device Yes ( ) No ( ) Sterile suction catheters Yes ( ) No ( ) Single-use suction bulb Yes ( ) No ( ) Newborn laryngoscope (with blades) Yes ( ) No ( ) Sterile endotracheal tubes Yes ( ) No ( ) Sterile gloves Yes ( ) No ( ) Sterile materials (cotton, gauze cloths) Yes ( ) No ( ) Thermometer Yes ( ) No ( ) Towels to dry the newborn Yes ( ) No ( ) Blanket to cover the mother and the newborn Yes ( ) No ( ) Cord clamping / cutting set Yes ( ) No ( ) Cord clamp Yes ( ) No ( ) Oxytocin Yes ( ) No ( ) Adrenaline Yes ( ) No ( ) Vitamin Ʉ Yes ( ) No ( ) 1% tetracycline ointment Yes ( ) No ( ) Syringes Yes ( ) No ( ) Newborn scale Yes ( ) No ( ) 6C - 19 Effective Perinatal Care (EPC Table 2. Check the Condition of the Delivery Room and the Working Condition of Equipment Is the birth room protected from draughts? Yes ( ) No ( ) Is the birth room well lit? Yes ( ) No ( ) Is there a clock with a second hand in the birth room? Yes ( ) No ( ) Is there equipment for free labouring positions in the birth room? Yes ( ) No ( ) Is the labour and birth room family friendly? Yes ( ) No ( ) The temperature in the birth room is: o 20-25 oC Yes ( ) No ( ) o Over 25 oC Yes ( ) No ( ) o Below 20 oC Yes ( ) No ( ) Does the heater function well? Yes ( ) No ( ) Air bag: o Self-inflating, of 250-750 ml? Yes ( ) No ( ) o Easy to assemble Yes ( ) No ( ) o Convenient to disinfect and sterilize Yes ( ) No ( ) o Without obvious damage Yes ( ) No ( ) Mask: o Anatomically shaped Yes ( ) No ( ) o With soft edges Yes ( ) No ( ) o Without obvious damage Yes ( ) No ( ) o Of 2 sizes Yes ( ) No ( ) Is the aspirator well functioning? Yes ( ) No ( ) o Manual/foot operated Yes ( ) No ( ) o Electric operation Yes ( ) No ( ) Incubator/heated cradle for the newborn Yes ( ) No ( ) o Clean Yes ( ) No ( ) o Temperature is about 35° C Yes ( ) No ( ) o Temperature is below 30° C Yes ( ) No ( ) o Temperature is above 38° C Yes ( ) No ( ) Is the scale well functioning? Yes ( ) No ( ) 6C - 20 Module 6C Table 3. Procedures Performed in the Delivery Room at Birth and Immediately after Birth Are relatives allowed to assist women in labour? Yes ( ) No ( ) Does healthcare staff wash their hands before conducting every examination? Yes ( ) No ( ) Does healthcare staff use sterile gloves for a birth? Yes ( ) No ( ) Does healthcare staff use only sterile instruments and equipment? Yes ( ) No ( ) Do they aspirate the newborn’s airways at birth? If yes please specify: o With the use of the aspirator o With the use of a bulb o Other _______________________ Yes ( ) Yes ( ) Yes ( ) Yes ( ) No ( ) No ( ) No ( ) No ( ) Is the newborn dried immediately after birth? If yes please specify: o Immediately after birth o In 30 minutes o With a dry warm towel /sheet Yes ( ) Yes ( ) Yes ( ) Yes ( ) No ( ) No ( ) No ( ) No ( ) Is the newborn assessed at birth? If yes – what is assessed: o Breathing o HBR o Skin colour o Floppiness o Weight o Length o Head circumference o Congenital malformations/birth trauma o Other ______________________ Yes ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) No ( ) When is the cord cut: o Immediately after birth o Within 1 minute after birth o More than 1 minute after birth ( ) ( ) ( ) What is used to clamp the cord? o A rubber band o A silk thread o A single-use clamp ( ) ( ) ( ) Where is the newborn placed immediately after birth? o On the table o On the mother’s chest (skin-to-skin contact) o Next to the mother o Other ___________ ( ) ( ) ( ) ( ) Is the newborn’s temperature taken after birth? If yes: o Within 30 minutes after birth o Within 2 hours after birth o More than 2 hours after birth o For all newborns o Only for the newborns with low birth weight or that are sick Yes ( ) ( ) ( ) ( ) ( ) No ( ) Are newborns bathed (specify): o Immediately after birth o Within 2-6 hours after birth o In warm water o In cold water Yes ( ) ( ) ( ) ( ) ( ) No ( ) 6C - 21 Effective Perinatal Care (EPC o Other _________________________________________ ( ) When is breastfeeding started? o When the newborn shows signs of readiness o Within the first 30 minutes o Within the first 4 hours o After the first 4 hours o After the first 12 hours ( ) ( ) ( ) ( ) ( ) Which preventative measures are taken when the baby is born? o Vitamin Ʉ administration o Gonoblenorrhea prevention o Other ( ) ( ) ( ) Is complete examination of the newborn performed in the delivery room? If yes: o Within 2 hours after birth o After 2 hours after birth o On a warm changing table Yes ( ) ( ) ( ) ( ) No ( ) 6C - 22 Module 7ɋ Breastfeeding Effective perinatal care (EPC) 7C - 2 Module 7C Slide 7ɋ-1 Breastfeeding The main objective of the module is to discuss the modern effective approaches to breastfeeding. By the end of the module the participants should: x Understand the importance of breastfeeding x Understand the danger of artificial feeding x Know the main mechanisms of breast milk production and let-down x Know the main characteristics of breast milk x Understand the importance of “skin-to-skin” contact for initiation of effective breastfeeding x Obtain skills to counsel women on first attachment to the breast x Know the correct breastfeeding positions x Be able to observe breastfeeding to provide supportive environment to the mother x Learn breastfeeding counselling skills x Learn the timely recognize of breastfeeding-related difficulties and help mothers to overcome them Slide 7ɋ-2 How do you Call These Types of Feeding? Picture 1: Exclusive breastfeeding: baby does not receive any water or food except breast milk. Picture 2: Predominant breastfeeding: baby receives a little water or other liquid in addition to breastfeeding. Picture 3: Artificial feeding: feeding baby with infant formula. Picture 4: Mixed feeding Picture 5: Complementary feeding: introduction of semi-solid or solid food to the baby’s nutrition from 6 months of age. Breastfeeding counselling: Training course. WHO, UNICEF,1993. 7C - 3 Effective perinatal care (EPC) Slide 7ɋ-3 Advantages of Breastfeeding Breast milk contains all vital components, macro and micro elements, needed for optimal physical, psychomotor, intellectual, emotional, and social development of the child. Cost-effective for the family, low-cost for health care system Decreases the likelihood of the mother to abandon her baby Breastfeeding counselling: Training course. WHO, UNICEF,1993. Feeding and nutrition of infants and young children. Guidelines for the WHO European Region, with emphasis on the former Soviet countries. WHO Regional Publications, European Series, No. 87, 2003. Slide 7ɋ-4 Risks of Artificial Feeding Artificial feeding can increase the risk of malnutrition and Vitamin A deficiency in children. Malnutrition is sometimes connected to the fact that the child is given a certain quantity of food, which is sufficient only for the energy supply of the body and not enough for his/her growth and development. Formula does not contain Vitamin A which can lead to a deficiency.. Mothers can become pregnant soon after delivery as prolactin’s production drops and fails to suppress ovulation (prolactin level is very high among breastfeeding mothers). The risk of developing anaemia, breast and ovarian cancers is higher amount women who don’t breastfeed. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Feeding and nutrition of infants and young children. Guidelines for the WHO European Region, with emphasis on the former Soviet countries. WHO Regional Publications, European Series, No. 87, 2003. 7C - 4 Module 7C Slide 7ɋ-5 How to Advise Mothers to Maintain High Levels of Prolactin When a child suckles the breast it produces an impulse that passes from the nipple to the brain. In response to this action, the hormone prolactin is secreted the front part of the hypophysis which then increases the production of milk. Within 30 minutes after breastfeeding a large amount of prolactin stays in the blood, which supports further production of milk for the next feeding. How can the production of breast milk be increased? The above-mentioned mechanism demonstrates that the more a baby suckles on the breast the more the mother’s breast produces milk. Thus, SUCKLING THE BREAST INCREASES THE VOLUME OF BREAST MILK. With these recommendations mothers can be taught to maintain high levels of prolactin in the body that will lead to adequate lactation. Some points about prolactin to remember: x Prolactin is produced abundantly at night; therefore night-time breastfeeding is especially useful for better milk production. x Prolactin suppresses ovulation, which is why breastfeeding helps to avoid new pregnancy. Night-time breastfeeding is especially important for this. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Feeding and nutrition of infants and young children. Guidelines for the WHO European Region, with emphasis on the former Soviet countries. WHO Regional Publications, European Series, No. 87, 2003. Slide 7ɋ-6 How to Advise Mothers to Maintain High Levels of Oxytocin When a child suckles the breast, the sensory impulses produced pass from the nipple to the brain. In response to these impulses, the hind part of hypophysis secretes the oxytocin hormone. Oxytocin passes from the blood to the breast and causes contraction of the muscle cells around the areola. As a result, the breast milk stored in the alveoli is let down from the glands into the lacteal sinuses and lacteal ducts, which usually cause the milk to flow out. This is called the “oxytocin” or “let down” reflex. Another important thing about oxytocin is that it causes the uterus to contract after delivery and thus can prevent postpartum haemorrhage. However, it can sometimes also cause pain in the uterus and blood inflow during breastfeeding within the first few days. 7C - 5 Effective perinatal care (EPC) There is an emotional component to having success with breastfeeding. It has been found that women with positive emotions while breastfeeding often have an easier time with the oxytocin reflex and the let down of milk to the breasts. Some things that influence positive emotions in women who are trying to breastfeed are touching the baby, positive thoughts about the baby, communicating with the baby, hearing the baby’s voice, and confidence that breastfeeding is the best nutrition for the baby. The flow of milk may be hindered if the mother is not feeling well, is experiencing pain, or has concerns or worries about breastfeeding. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 7ɋ-7 Other Things that Help Mothers Breastfeed Are: With very simple means you can help the mother to avoid problems connected with insufficient production of oxytocin. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-8 Suckling Process Suckling mechanism: the child makes “pressing” movements with his tongue. Milk from the milk sinuses gets into his mouth and he collects some amount of milk and then swallows it. That’s why it is important to properly attach him to the breast. Michael W. Woolridge. The anatomy of infant sucking. Midwifery. 1986 Dec; 2(4): 164-71. 7C - 6 Module 7C Slide 7ɋ-9 Vital Components of Breast Milk Among anti-infectious proteins found in breast milk, the most important ones are: iron-binding lactoferrin, which prevents bacteria growth and hinders its replication; lysozyme, which also destroys bacteria; as well as antibodies, such as immunoglobulin A (IgA). The other important anti-infectious factor is the bifidus factor, which facilitates the growth of lactobacillus bifidus, which inhibits the replication of harmful bacteria. Breastmilk also contains anti-viral factors. An exclusively breastfed child gets 0.5 g of IgȺ per day. Secretory IgȺ (from breastmilk) protects the baby from harmful microorganisms, such as E. coli. It also limits antigen penetration. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-10 Protection from Infections When a mother has an infection, her body produces antibodies to fight this infection. These antibodies are transferred to the baby through the breast milk, thereby protecting the baby. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 7ɋ-11 Colostrum and Breast Milk 7C - 7 Effective perinatal care (EPC) The composition of breast milk changes as the baby gets older and from the beginning to the end of each feeding session. The first type of breast milk that is produced is called colostrum. This contains antibodies and white cells, which provide the primary immunization, growth factors, and vitamin A. Colostrum also has a mild purgative effect, which helps the baby to get rid of meconium and bilirubin. Mature milk is the type of milk that is produced after the baby is a few days old. It contains both foremilk and hindmilk. Foremilk has a large proportion of water, has a bluish tint and is produced early in the feeding session. Hindmilk is more nutritious, is whiter in colour and is produced later in the feeding session. The hindmilk is higher in fat content than the other types of breast milk, so it is especially important that low-weight babies receive this milk. When a woman has limited caloric intake, she can still produce breast milk. What she eats does not affect the production of breast milk; however, she should eat a varied and healthy diet. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-12 First Breastfeeding (1) For skin-to-skin contact the child should be placed between the mother’s breasts immediately after birth. Remember that the child needs to rest. Every infant is different so the resting period for each one is unique; it can last from 30 to 40 minutes. After that the child should show signs of readiness for breastfeeding. Help the mother and the child to get into a comfortable position together. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 “Mother and Infant Health” Project. Ukraine. JSI/USAID, 2004. 7C - 8 Module 7C Slide 7ɋ-13 First Breastfeeding (2) Tell the mother to place her child in a position which is the most comfortable for the baby to attach to the breast when it starts showing signs of readiness for breastfeeding. All this might take an hour or longer after the birth. The baby will open his mouth widely and start moving his head from one side to another. “Mother and Infant Health” Project. Ukraine. JSI/USAID, 2004. Slide 7ɋ-14 First Breastfeeding (3) Photo of the child with signs of readiness for breastfeeding. “Mother and Infant Health” Project. Ukraine. JSI/USAID, 2004. Slide 7ɋ-15 First Breastfeeding (4) Let the child attach himself to the breast when he is ready. The healthcare provider SHOULD NOT attach the baby to the mother’s breast. However when the child is attached to the breast, assess the attachment and the baby-mother position. Help the mother to correct anything that’s been done improperly and give her practical assistance if she needs it or asks for it. “Mother and Infant Health” Project. Ukraine. JSI/USAID, 2004. 7C - 9 Effective perinatal care (EPC) Slide 7ɋ-16 First Breastfeeding (5) Let the child be the one who determines when it is finishes suckling from one breast before you switch it to the other one. The mother can breastfeed her child in both the lying and sitting position. It’s not important which position is selected for breastfeeding, the important factor is that both the mother and her child should feel comfortable. The first breast milk (colostrum) is very important because it protects the child from many diseases. Colostrum also contains important growth factors which help the intestinal tract, brain, nervous system and eyes of the baby to mature. No food or water should be given to the newborn, only the colostrum. Otherwise, the baby will be deprived of important protective and maturation factors which are contained in it. Colostrum is usually produced in a small amount. Colostrum contains protective factors in a large concentration, which are needed for the child’s health. The intake of colostrum by the child is a natural form of immunization. Let the child suckle the breast as long as he wants. Do not interfere. When he stops to suckle one breast offer him the other one. Create conditions for the mother and baby to have constant rooming-in. Postpartum mother-baby rooming-in is very important as it helps to create special bonding between them. Most of the medical procedures with the mother can be performed when she and her baby are in skin-to- skin contact. “Mother and Infant Health” Project. Ukraine. JSI/USAID, 2004. Slide 7ɋ-17 First Breastfeeding (6) Breastfeeding is important for both the mother and baby. Women who breastfeed their babies usually do so both because they believe it is best for their babies and because they find it satisfying and enjoyable. The timing of the first feed, positioning, feeding frequency and duration, supplements for babies and mothers, and support for breastfeeding mothers, can all affect the establishment and maintenance of breastfeeding. Early contact between the mother and baby has beneficial effects on breastfeeding, in addition to other important benefits. It is difficult to separate the effects of early suckling per se from the effects of other early mother- baby interactions, such touching, gazing, and skin to skin contact. Feeding within the first 2 hours after birth increases the duration of breastfeeding when compared to a delay of 4 hours or more. The first feed after birth (as opposed to the immediate post delivery nuzzle at the breast) should be given in privacy, at the time when the baby is receptive, and after the mother and the baby have been made comfortable. Skilled professional help can be useful at this time. Murray W. Enkin et al., A guide to effective care in pregnancy and childbirth. Oxford university press. Third edition. 2000 7C - 10 Module 7C Slide 7ɋ-18 Assessing Attachment (1) On the slide you can see signs of improper attachment of the baby: x mouth is not open widely x lower lip is turned in x chin does not touch the breast x areola is seen both above the baby’s upper lip and below the lower one x lips are stretched forward Actions which the mother can do to help with proper attachment of the baby to her breast: x touch the baby’s lips or cheeks x wait till the baby opens his mouth widely x put the baby close to the breast so that his lower lip is below the nipple Slide 7ɋ-19 Assessing Attachment (2) You can see the following signs of the baby’s attachment on the first picture: x Lower lip is turned outwards x Chin doesn’t touch the breast x Baby suckles the nipple x Lips are stretched forward x Baby ‘s body is not close to mother’s x Baby’s head and body are not straight and are not in the same line with mother’s body Advise the mother: x To take the baby away from the breast and start again x Hold the baby close to the mother’s body x Hold the baby so that he faces the breast x Make sure that the baby’s lips and nose are against the nipple On the second picture the following signs are seen: x Mouth is open widely x Lower lip is tuned outward x Chin touches the breast x Upper part of areola seen more than the lower part Integrated Management of Childhood Illness (IMCI), Training Course, WHO, 1997 7C - 11 Effective perinatal care (EPC) Slide 7ɋ-20 4 signs of proper attachment to the breast Signs of proper attachment should be assessed by a healthcare provider as often as possible. When the child is not properly attached to the breast, help the mother to find the proper position for her and her baby. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 7ɋ-21 Some Breastfeeding Positions The mother can choose any position that she finds comfortable for breastfeeding. She can lie on her back or on one side; she can also sit on a chair with her legs crossed. She can breastfeed her child bending over him or in a standing position. The mother can breastfeed in a lying position at night and a sitting position in day time It is important to allow the woman to find the most comfortable position that works for her and her baby for breastfeeding, given that after birth some mothers may have pain in their perineum; be tired; suffer from breast engorgement; have mastitis or flat or inverted nipples. Likewise, The baby could have characteristics that could affect breastfeeding, such as their size; they may also be premature; or they could have physical or oral abnormalities (e.g. cleft lip or palate) that make it more difficult to find a comfortable position for breastfeeding. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 7ɋ-22 How to Assess Breastfeeding (1) The mother’s behaviour: whether she is tired or worried. How the mother holds her baby: whether all signs of proper attachment are followed. The child’s behaviour: whether the child is calm at the breast, whether he suckles actively. Whether the child cries or refuses the 7C - 12 Module 7C breast. Whether the mother has chosen a comfortable position and all signs of proper attachment are maintained. Pay attention: whether the mother holds her breast during breastfeeding, whether she uses “scissors”- like position of her fingers. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-23 How to Assess Breastfeeding (2) Are the signs of proper attachment followed? Does the child suckle the breast effectively and are swallowing sounds heard? How did the breastfeeding end – did the baby stop it spontaneously or did the mother withdraw the breast? Whether the child is satisfied with breastfeeding: whether he cries or is restless. Assess whether there is engorgement/blocked ducts, nipple cracks on the mother’s breast. Assess the mother’s mood and state (tiredness, dissatisfaction, etc) after breastfeeding. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-24 How to Observe: On the slide you can see the main characteristics of how to properly observe a woman breastfeeding. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 7C - 13 Effective perinatal care (EPC) Slide 7ɋ-25 Difficulties which May Lead to the Mother’s Anxiety On the slide the main reasons for difficulties in initiation of breastfeeding for the mother are listed. Breast conditions can include: blocked ducts, engorgement and cracks. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 7ɋ-26 “Not Enough Milk” Hypogalactia (the condition of not enough milk) only occurs in 1% of women. The mother should be informed about this as soon as possible after delivery to reduce her worries. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Slide 7ɋ-27 Congenital Abnormalities Most children with cleft lip can be breastfed. It’s important to encourage the mother to breastfeed; choose the position that is most comfortable for her and her child. Children with cleft palate can have difficulties in attachment to the breast and suckling. However, if the mother is able to support the breast and position the baby correctly then breastfeeding is possible. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 7C - 14 Module 7C Slide 7ɋ-28 Breast Conditions Which Can Cause Problems with Breastfeeding On this slide you can see the list of the breast conditions which can cause problems with breastfeeding. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-29 Babies Can be Breastfed by Any Type of Breast In the case of anatomical abnormalities of the breast: x Make the mother confident that she will be able to breastfeed x Help her to get into comfortable position for her and her baby; try several options x With flat or inverted nipples try to use a suctioning device, such as a syringe or milk pump; milk expression is also possible in order to cup-feed the baby; the mother can express milk directly into baby’s mouth. Breastfeeding counselling: Training course. WHO, UNICEF,1993. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-30 Management of Flat and Inverted Nipples Antenatal treatment: x Most efforts to “prepare” the breasts before birth, such as stretching the nipples or wearing special shields, are not very effective. The nipples improve their shape by the time of birth. After birth: x Make the mother feel confident x Help the mother to correctly position the baby at the breast x Try different positions 7C - 15 Effective perinatal care (EPC) x Help the mother to make the nipples stand out using syringe or milk pump x Teach the mother to express the milk and cup feed x Express the milk directly into baby’s mouth Breastfeeding counselling: Training course. WHO, UNICEF,1993. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-31 Cup Feeding On the slide you can see principles of cup feeding. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 Slide 7ɋ-32 Following Factors Hinder Breastfeeding On the slide there is a list of factors that can hinder breastfeeding. The optimal duration of exclusive breastfeeding. A Systematic Review. WHO, 2001 7C - 16 Module 7C Slide 7ɋ-33 Conclusion (1) Those who care for women during pregnancy and childbirth have a crucial role to play in enabling a woman to breastfeed successfully. Women can be helped to establish and maintain breastfeeding in a number of ways, but experimentally-derived evidence suggests that continuity of personal support from an individual who is knowledgeable about breastfeeding is most effective. Murray W. Enkin et al., A guide to effective care in pregnancy and childbirth. Oxford university press. Third edition. 2000 Slide 7ɋ-34 Conclusion (2) For up to the first 6 months of life, exclusive breastfeeding can provide all the nutrients and water that a baby needs. From the age of 6 months breast milk is no longer sufficient by itself. After 6 months all babies should receive other foods known as complementary foods in addition to breast milk. However, breast milk continues to be important source of energy and high quality nutrients throughout the second year of life and beyond. Essential Newborn Care and Breastfeeding. WHO EURO, 2002 7C - 17 Effective perinatal care (EPC) B-R-E-A-S-T-FEED OBSERVATION FORM Mother's name: __________________________________ Date: _________________ Baby's name: ____ _____________________ ________ Age of baby: __________ [Signs in brackets refer only to newborn, not to older babies] Signs that breastfeeding is going well Signs of possible difficulty BODY POSITION Mother relaxed and comfortable Baby's body close, facing breast Baby's head and body straight Baby's chin touching breast [Baby's bottom supported] ҎShoulders tense, leans over baby ҎBaby's body away from mother's ҎBaby's neck twisted ҎBaby's chin not touching breast Ҏ[Only shoulder or head supported] RESPONSES Baby reaches for breast if hungry [Baby roots for breast] Baby explores breast with tongue Baby calm and alert at breast Baby stays attached to breast Signs of milk ejection, [leaking, afterpains] ҎNo response to breast Ҏ[No rooting observed] ҎBaby not interested in breast ҎBaby restless or crying ҎBaby slips off breast ҎNo signs of milk ejection EMOTIONAL BONDING Secure, confident hold Face-to-face attention from mother Much touching by mother ҎNervous or limp hold ҎNo mother/baby eye contact ҎLittle touching or ҎShaking or poking baby ANATOMY Breasts soft after feed Nipples stand out, protractile Skin appears healthy Breast looks round during feed ҎBreasts engorged ҎNipples flat or inverted ҎFissures or redness of skin ҎBreast looks stretched or pulled SUCKLING Mouth wide open Lower lip turned outwards Tongue cupped around breast Cheeks round More areola above baby's mouth Slow deep sucks, bursts with pauses Can see or hear swallowing ҎMouth not wide open, points forward ҎLower lip turned in ҎBaby's tongue not seen ҎCheeks tense or pulled in ҎMore areola below baby's mouth ҎRapid sucks only ҎCan hear smacking or clicking TIME SPENT SUCKLING Baby releases breast Baby suckled for ___ minutes ҎMother takes baby off breast Notes: Adapted with permission from "B-R-E-A-S-T-Feeding Observation Form" by H C Armstrong, Training Guide in Lactation Management, New York, IBFAN and UNICEF 1992. 7C - 18 Module 8C Postpartum Care of Mothers and Newborns Effective Perinatal Care (EPC) 8C - 2 Module 8C Slide 8C-1 Postpartum Care of Mothers and Newborns By the end of this module the participants will: x Understand the importance of effective postpartum care for mothers and newborns x Gain effective and useful skills in mother and newborn postpartum care x Understand the advantages of breastfeeding for mothers and newborns x Understand the principles of correct breast attachment x Understand existing methods of family planning for the first 6 months of the postpartum period Slide 8C-2 Four Basic Principles of Postpartum Care In the early postpartum period, serious health problems can develop. Unless appropriately revealed and resolved, they can result in long-term negative consequences for the newborn or even newborn death. However, the importance of postpartum care is not widely recognized. The postpartum period is when a woman’s organs begin to revert to their initial condition and lactation is initiated. Physiological changes occur for 6-8 weeks. The first week after delivery is associated with the most critical changes. In this period the basis for the restoration of the woman’s health is established and mutual adaptation of the mother and child occurs. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 8C - 3 Effective Perinatal Care (EPC) Slide 8C-3 Principles of Postpartum Care (1) Symptoms of postpartum complications, such as haemorrhage, eclampsia and infection, should be discovered in the first several hours after delivery. Appropriate treatment should be prescribed. Close monitoring of a woman’s condition prevents ineffective routine measures such as sonograph at discharge, speculum examination and prescribing clinical analysis. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 Slide 8C-4 Principles of Postpartum Care (2) The midwife plays an important role in postpartum care. She is responsible for providing care which must be individualized for each woman and infant. Urination should be monitored. If the bladder is excessively full the uterus may relax, causing bleeding from the uterus. Difficulties when urinating are common and may cause postpartum haemorrhage. The mother should be encouraged to urinate within 8 hours of delivery. Mothers should be encouraged to walk about within a few hours of delivery. However, the mother should be assisted the first time she gets out of bed to go to the bath or shower as she may feel weak and faint. Signs of postpartum complications, such as haemorrhage, eclampsia and infection, must be looked for and properly treated. Encourage the mother to return to activity by getting up, moving and taking a shower as soon as possible after the delivery. This will help the mother to better take care of and establish a relationship with her newborn. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 8C - 4 Module 8C Slide 8C-5 Full Time Rooming-in Encouraging full time rooming-in was compared to separation of mothers and newborns in the early postpartum period in randomized controlled trials (RCTs). Evidence shows that when contact between the mother and newborn is limited, mothers show fewer mothering feelings, are frustrated and have lower self-esteem. Separating mothers and newborns increases the risk of children being neglected by first-time parents. Routine practice of mother and newborn separation may have a negative effect on the duration of further breastfeeding. In all RCTs examining this issue, the number of women who stopped breastfeeding one to three months after delivery was considerably higher among the mothers who were separated from their children after birth. Prevention of maternal and neonatal infection cannot be neglected. Preventive measures must be continuously looked for and assessed. The implementation of restrictive measures without a proper assessment of their efficacy is not a solution (mother and newborn separation, using antiseptics for cord care, bathing newborns with the addition of medicine, obligatory hospital gowns, caps and masks wearing, prohibition of visits from relatives). Full time rooming-in during the first 24 hours adds an element of protection due to the newborn’s skin being contaminated with saprophytic microorganisms from the mother’s skin, rather than with antibiotic-resistant hospital microflora. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 Slide 8C-6 Postpartum Exercises Postpartum exercises should begin one day after delivery and continue for at least three months. These exercises should take five minutes twice a day. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 8C - 5 Effective Perinatal Care (EPC) Slide 8C-7 Prophylaxis of Mammary Gland Infection Early and exclusive breastfeeding, correct breast attachment and feeding on demand enables the mother to avoid nipple cracks, lactostasis and mastitis. There is no need to wash breasts before every feeding. There is no need to use any cream, ointment or lotion on the nipples. None of these measures are effective in nipple crack prophylaxis. Nipples should be dry and clean. It is recommended to apply several drops of milk or colostrum to the nipples after feeding. Breastfeeding counselling: Training course. WHO, UNICEF, 1993 Slide 8C-8 Typical Postpartum Problems Pain relief was studied and observed in RCTs. Cooling the vaginal and perineal area with pieces of ice (ice packs or bags of ice) temporarily relieves symptomatic pain. Local administration of anesthetics (5% lidocainum) in a spray or gel form has a more prolonged effect. The use of non- steroid analgesics has more adverse effects than benefits. Perineal pain relief can have an important difference in the quality of individual care. Paracetamol can be taken orally as pain medication. If not effective, other non-steroid analgesics such as ibuprofen can be used. Until recently pain relief and pain prophylaxis were not priorities of RCTs. A woman’s psychological and emotional status is negatively affected by the absence of psychological support. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 8C - 6 Module 8C Slide 8C-9 Major Postpartum Complications and Diseases Postpartum haemorrhage is one of the main reasons of maternal mortality. About 150,000 women per year die of postpartum haemorrhage and 90% of these deaths happen within the first two hours after delivery. Postpartum infections, such as sepsis, are still a considerable cause of maternal deaths, especially in developing countries. Eclampsia is the third largest cause of global maternal deaths. Urinary tract diseases (infections, urinary retention and urinary incontinence) are also widespread. Perineal and vaginal pain from lacerations or episiotomies in the second stage of labour are also common. Regular examination is necessary to identify infections. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 Slide 8C-10 Ineffective Practices in Postpartum Maternal and Neonatal Care There is indisputable evidence that such practices are ineffective. All practices mentioned were observed in multiple trials and their ineffectiveness was confirmed. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth. Oxford University Press, 3rd Edition, 2000 Slide 8C-11 Four Basic Needs of Newborns Love: it is important for newborns to be surrounded by family, to communicate with parents and to be loved by them. A newborn’s interaction with its mother and family is significant for its development and diverse biological and social mechanisms are used. The father must participate actively in the delivery and postpartum newborn care. It’s been shown in RCTs that a newborn may start crying loudly upon separation from its mother. As soon as contact is restored the newborn becomes calm. This cry is called a “distress cry”. 8C - 7 Effective Perinatal Care (EPC) Christensson K, Cabrera T, Christensson E, Uvnas-Moberg K, Winberg J. Separation distress call in the human neonate in the absence of maternal body contact. 1: Acta Paediatr. 1995 May;84 (5):468-73 Warmth: A normal newborn’s body temperature is 36.5-37.5°ɋ. If it falls below 36.5°ɋ hypothermia develops. To avoid hypothermia, a warm-chain must be kept. Swaddling: Swaddling doesn’t prevent hypothermia. Turkish trials conducted by Yurdakok determined that swaddled babies have pneumonia four times as often as those babies that are not swaddled. (Yurdakok K et al. 1990) A RCT (Fardia,1980) showed, that a newborn’s body temperature is higher in direct skin-to-skin contact than under a heater: “the earlier and longer skin-to-skin contact with the mother is provided, the better the newborn maintains body temperature”. A RCT conducted by Ludington-Hoe and Anderson demonstrated that skin-to-skin contact can protect a preterm baby from hypothermia, hypoxia, breathing difficulties, apnoea and decreased heart rate. An increase in the rate of infection diseases wasn’t detected and the duration of regular sleep was higher. Early exclusive breastfeeding until 6 months of age: The advantages of breastfeeding for mother and child have been proven by many RCTs and summarized by WHO in the book “10 Steps of Successful Breastfeeding”. Infection prevention: principles of cleanliness must be followed at birth and in postpartum care. Newborn health and survival. A call for action. WHO, USAID, 2006 Slide 8C-12 Advantages of Breastfeeding UNICEF data show that every day about 4,000 newborns die as a result of adverse consequences of artificial feeding. Marketing codex of human milk substitutes issued by WHO (1981) and the declaration of protection, promotion and support of breastfeeding by WHO and UNICEF (1989) support breastfeeding and regulating the marketing of human milk substitutes, instilling self-confidence in a woman’s ability to breastfeed. The advantages of breastfeeding were shown by Widström et al (1990). This trial demonstrated that early initiation of breastfeeding within the first 30 minutes of a newborn’s life has a positive influence on the relationship between the mother and newborn. Breastfeeding counselling: Training course. WHO, UNICEF, 1993 Evidence for the ten steps to successful breastfeeding, WHO, 1998 8C - 8 Module 8C Slide 8C-13 Ten Steps of Successful Breastfeeding (1) The majority of problems related to breastfeeding and its rejection are a result of incorrect feeding methodology. The most important steps in overcoming these difficulties are described in the book “10 Steps of Successful Breastfeeding”. Evidence for the ten steps to successful breastfeeding, WHO, 1998 Slide 8C-14 Ten Steps of Successful Breastfeeding (2) The most important steps of overcoming these difficulties are described in the book “Evidence for the ten steps to successful breastfeeding”. Evidence for the ten steps to successful breastfeeding, WHO, 1998 Slide 8C-15 Breastfeeding Challenges The lack of breast milk (inability to produce breast milk) is rather uncommon, occurring in one to two cases per 10,000 mothers. However, currently the most common reason for the termination of breastfeeding and the switch to artificial feeding is the mother’s belief that she lacks breast milk. One reason for breast milk shortage is incorrect attachment to the breast. Changing the newborn’s feeding position and expressing a few drops of breast milk before feeding can be recommended to improve the situation. Flat or inverted nipples: there is an incorrect belief that flat or inverted nipples can hamper the sucking of a breast. If attached correctly, the baby sucks not only the nipple (one third) but a part of the breast as well (two thirds). Breast tissue is elastic and is able to stretch. The first few days are often difficult as the mother and newborn adapt to each other. In this case medical staff should support the mother and encourage her to be patient with the process of adjustment. Correct attachment will instill confidence in the mother that breastfeeding will become easier. 8C - 9 Effective Perinatal Care (EPC) Long nipples: In this case the baby seizes only the nipple and doesn’t suck out enough milk. Help the baby to seize more breast tissue. Sometimes feeding is possible when the baby latches on to the bigger part of the nipple and areola. Expressed milk should be offered to the baby after breastfeeding because the baby is not always able to suck a sufficient amount of milk. The absence of protective immune complexes in artificial feeding makes it much more dangerous for baby than breastfeeding by a sick mother. In certain cases alternative feeding methods may be necessary, but breastfeeding should be considered first. If the mother is taking cytostatic, radioactive or anti-thyroid drugs, breastfeeding must be postponed for the period of treatment. All drugs with possible adverse effects on the newborn or lactation should be replaced with alternatives that are approved for use during breastfeeding. If the mother is prescribed drugs that can be taken while breastfeeding, measures must be taken to limit the ingestion of the drug by the baby through breast milk. It can be recommended that the mother takes the drug just after a feeding in which case the concentration of the drug in the breast milk at the next feeding is reduced. Breastfeeding counselling: Training course. WHO, UNICEF, 1993 Slide 8C-16 Differences between Breast Filling and Engorgement All medical staff should be trained to distinguish between breast engorgement and filling, because of the different management of these two conditions. Breastfeeding counselling: Training course. WHO, UNICEF, 1993 Slide 8C-17 Breast Engorgement Solutions: x If the baby can suck the breast, feed him/her frequently and help him/her to attach correctly to the breast. x If the baby doesn’t suck, milk should be expressed and fed to the baby. x Teach the mother to stimulate the oxytocin reflex before feeding: take a warm shower or apply a warm compress, massage the neck and back, lightly massage the breast, help the mother to relax. x If there is breast edema, apply a cold compress to the nipple after feeding. Breastfeeding counselling: Training course. WHO, UNICEF, 1993 8C - 10 Module 8C Slide 8C-18 Nipple Cracks Nipple cracks can occur in the initial stage of breastfeeding, when correct attachment to the breast is not yet well-mastered. Solutions: x Help the mother to correctly attach the baby to the breast. x Do not wash the breast before every feeding with soap. Creams, ointments and lotions are not effective in managing nipple cracks. Several drops of milk or colostrum can be applied to the nipple before and after feeding. x Continued pain can be conditioned by nipple moniliasis. Breastfeeding counselling: Training course. WHO, UNICEF, 1993 Slide 8C-19 Prophylaxis of Neonatal Infection Basic principles of cord care: the cord must be kept clean and the use of antiseptics should be avoided. The cord shouldn’t be covered by diapers or any type of bandage. If contaminated, the cord should be washed with warm water and dried thoroughly with a clean napkin. The analysis of 10 RCTs found no advantages to using antiseptics in cord management when compared to dry cord management. Managing newborn problems: A guide for doctors, nurses and midwives. WHO, 2003 Slide 8C-20 Support of Mother’s Self- Confidence The postpartum period is a unique opportunity for the family to find new ways (patterns) of communication. Husbands should visit mothers and newborns and help to relieve the mother’s anxiety with the new family situation. Medical staff shouldn’t take care of the newborn, but instead constantly train and counsel the mother and father in appropriate newborn care. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002. 8C - 11 Effective Perinatal Care (EPC) Slide 8C-21 General Support and Training of the Mother A number of RCT studies were conducted worldwide to determine the efficacy of different methods of postpartum training. Despite the absence of a complete consensus in recommendations regarding what should be included in a program of postpartum training, these programs have a positive influence on parent behaviour and family health indices. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 Slide 8C-22 Family Planning – Lactational Amenorrhea Method The high effectiveness of the lactational amenorrhea method is achieved by observing all mentioned conditions. The advantages of this method include that it is cheap, high-performing (98%- 99%) and a natural method of family planning. The lactational amenorrhea method should be recommended in the maternity. World Health Organization. Improving access to quality care in family planning: medical eligibility criteria for contraceptive use. Geneva: WHO, 1996 Slide 8C-23 Family Planning - Selecting the Method Counseling in family planning methods should be individual. The choice of method depends on: x How the baby is being fed x The safety, availability and duration of the method x The method’s effectiveness x The likelihood of side effects x The woman’s choice and the relationship between the couple x Concomitant diseases x The woman’s sexual behaviour Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 8C - 12 Module 8C Slide 8C-24 Danger Signs in Women in the Postpartum Period Women should be informed of postpartum period danger signs while in the maternity. As a result of counseling, women will be able to recognize danger signs and know that they should refer immediately to a healthcare institution. Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 Slide 8C-25 Danger Signs in Baby Women should be informed while in the maternity about baby’s danger signs, in appearing of which she must go to the health center immediately day or night, WITHOUT waiting. Essential Newborn Care Course Training Manual (Draft).WHO, Geneva. 2006 Neonatal IMCI (draft).WHO.2006 Integrated Management of Pregnancy and Childbirth. Pregnancy, Childbirth, Postpartum and Newborn Care: A guide for essential practice. WHO, Geneva, 2006 Slide 8C-26 Discharge from the Maternity after a Normal Delivery Before making a decision about discharging women and newborns from the maternity, consider all factors, including mother and infant health status as well as the mother’s social and individual needs. In some cases, early discharge (before 24 hours) is possible if it is certain it will not lead to any adverse health consequences for the mother and the infant. Early discharge has certain advantages in reducing the likelihood of hospital infections, and the woman often feels more comfortable at home during the postpartum period. Several RCTs and descriptive studies revealed that only a few women and infants need extended and/or recurring hospitalization. 8C - 13 Effective Perinatal Care (EPC) Screening and vaccination should be carried out according to existing national protocols. Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO Geneva, 1996 Care in normal birth: A practical guide. Report of a technical working group. WHO, 1997 Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 Slide 8C-27 Discharge of the Mother from the Maternity Criteria for a mother’s discharge from the maternity are shown on the slide. Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO Geneva, 1996 Care in normal birth: A practical guide. Report of a technical working group. WHO, 1997 Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 Slide 8C-28 Discharge of the Newborn from the Maternity What the mother should do at home: x Keep the newborn’s cord dry and clean x Keep the baby warm x Breastfeed the newborn on demand x Be aware of postpartum danger signs Mother-Baby Package: Implementing safe motherhood in countries. Practical guide. WHO Geneva, 1996 Care in normal birth: A practical guide. Report of a technical working group. WHO, 1997 Essential Antenatal, Perinatal and Postpartum Care. WHO EURO, Copenhagen, 2002 8C - 14 Module 9C Neonatal Resuscitation Effective Perinatal Care (EPC) 9C - 2 Module 9C Slide 9C-1 Neonatal Resuscitation Module objectives: At the end of the module the participants will be able to: x Be ready for neonatal resuscita- tion in every newborn x Ensure appropriate environment and equipment for every birth x Do the initial assessment of new- born status to decide when to start resuscitation x Provide neonatal resuscitation through a continuous Assess- Classify-Manage cycle x Understand the importance of the team approach for neonatal resuscitation. Slide 9C-2 How Many Newborns Re- quire Resuscitation? Although the vast majority of newborns do not require intervention to make the tran- sition from intrauterine to extrauterine life, approximately 1% of newborns require extensive resuscitative measures such as intubation, chest compression and drug administration. 2005 American Heart Association Guide- lines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resuscitation Guide- lines. Circulation. 2005; 112:IY-188 – IY- 195 Slide 9C-3 Resuscitation at Birth Newborn resuscitation is different from the resuscitation of all other age groups. Although the majority of babies will estab- lish normal respiration and circulation without help after delivery, those babies who do not establish adequate regular normal breathing, or who have a heart rate of less than 100 beats per minute, require assistance. Despite the limitation of the available evi- dence, an international body of experts has provided guidelines for neonatal re- suscitation. Wyllie, J. Resuscitation of the depressed newborn. Seminars in Fetal and Neonatal Medicine. Volume 11, Issue 3,June 2006. 158-165. 9C - 3 Effective Perinatal Care (EPC) Slide 9C-4 Effective Neonatal Resusci- tation (1) Effective neonatal resuscitation is a cost- effective intervention with proven efficacy for neonatal survival. Universal coverage of this intervention could prevent about 40% of neonatal deaths worldwide. Darmstadt, GL et al. for the Lancet Neo- natal Survival Streeting Team. Evidence- based, cost-effective interventions: how many newborns can we save? The Lan- cet. Mar 12-18, 365 (9463), 977-88. Slide 9C-5 Effective Neonatal Resusci- tation (2) Anticipation, adequate preparation, accu- rate assessment, and prompt initiation of support are critical for successful neona- tal resuscitation. Resuscitation must be anticipated at every birth. Every birth attendant should be prepared and able to resuscitate since, if it is necessary, resuscitation should be initiated without delay. Every birth atten- dant must be trained in resuscitation and must have resuscitation equipment and supplies in perfect condition. At every birth there should be at least one person who must be able to initiate resuscitation. In addition, a qualified staff trained in extensive resuscitation needs to be readily available. A clean and warm delivery room, as well as all necessary resuscitation equipment, must be prepared for every birth. Local guidelines indicating who should attend births and which equipment and supplies should be prepared for each birth need to be developed based on current practice and clinical audit. Basic Newborn Resuscitation: a practical guide. World Health Or- ganization, Geneva, 1997. European Resuscitation Council Guidelines for Resuscitation 2005: Sec- tion 6. Paediatric life support, Resuscitation of babies at birth. Resuscita- tion. 2005, 6751, S115-S133 9C - 4 Module 9C Slide 9C-6 Is Neonatal Resuscitation Predictable? Some maternal and foetal conditions which are risk factors for the need for neonatal resuscitation at birth are listed on this slide. Good management of pregnancy, as well as labour/delivery complications, is the best means of preventing needs in neo- natal resuscitation. Basic Newborn Resuscitation: a practical guide. World Health Organization, Ge- neva,1997. Slide 9C-7 In 50% of Births the Need for Neonatal Resuscitation Is Not Pre- dictable Although it is often possible to predict the need for resuscitation before a baby is born, this is not always the case. Up to half of newborns who require re- suscitation have no identifiable risk fac- tors before birth – Therefore it is not enough to be prepared only in cases where one or more risk fac- tors are present. It is essential to prepare environment and equipment before every birth of the baby. All equipment must be checked daily. An institution in which births occur must develop and administer a training program on stan- dards and skills required for resuscitation of the newborn. Basic Newborn Resuscitation: a practical guide, World Health Organisa- tion, Geneva,1997 European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Thomson O'Brien MA, Freemantle N, Oxman AD, et al.Continuing education meetings and workshops: effects on professional practice and health care out- comes. Cochrane Database Syst Rev 2001;(2) 9C - 5 Effective Perinatal Care (EPC) Slide 9C-8 Preparation for Every Birth Resuscitation should ideally take place in a warm, well-lit, draught-free area with a flat surface that can be used for resuscita- tion that is ideally under a radiant heater. Key resuscitation equipment should be available immediately nearby. Warm and dry towels: each newborn must be dried with warm towels; wet towels must be removed immediately. A clock with a second hand is necessary for precise timing of all neonatal resuscita- tion steps. Attendants must wash hands their hands with water and soap when preparing for the birth. It is necessary to have sterile gloves for the birth attendant (if sterile gloves are not available, the attendant should disinfect their hands before starting resuscitation or use clean gloves); and sterile instrument (scalpel or scissors) for cutting the umbilical cord. The birth attendant should use clean instrument (scalpel or scissors) for cutting the umbilical cord If sterile instrument are not available (e.g. home delivery). European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-9 Resuscitation Equipment to Be Checked before Every Birth Resuscitation equipment should be checked and be in working condition. The equipment must be disinfected after each use. Newborn resuscitation requires: x Bag: it is recommended to use a self- inflating bag for neonatal resuscita- tion with a volume 250-400 ml. The bag compression must generate the pressure of at least 45 cm water. The bag must be convenient for use and disinfection after every use. x Masks in 2 sizes: 0 for preterm newborn, 1- for full-term newborn x Equipment for suctioning: mucus extractor, bulb or catheter x Intubation equipment: laryngoscope with blades for newborns, intubation tubes of different sizes, adapter for suctioning, wire, Magill forceps x Drugs (adrenaline and normal saline) and sterile syringes. An institution should have at least two sets of equipment in case of multiple births (twins), for other births occurring at the same times, or in the case that one set does not function. The standard approach to resuscitation is to use 100% oxygen. Some clinicians may begin re- suscitation with an oxygen concentration of less than 100%, and some may start with no sup- plementary oxygen (ie, room air). There is evidence that employing either of these practices 9C - 6 Module 9C during resuscitation of neonates is reasonable. If the clinician begins resuscitation with room air, it is recommended that supplementary oxygen be available to use if there is no appreciable im- provement within 90 seconds after birth. Basic Newborn Resuscitation: a practical guide. World Health Organisa- tion, Geneva, 1997 European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-10 To Initiate and Manage Neonatal Resuscitation Assess (1) The key sign to assess before and during resuscitation is the breathing of the baby. Check whether the baby is breathing. If so, evaluate the rate, depth and symme- try of respiration, together with any ab- normal breathing pattern such as gasping and grunting. European Resuscitation Council Guide- lines for Resuscitation. Section 6: Paedi- atric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-11 To Initiate and Manage Neonatal Resuscitation Assess (2) Heartbeat rate: the best evaluation is to listen to the apex beat with a stethoscope. Feeling the pulse in the base of the um- bilical cord is often effective but can be misleading. Cord pulsation is only reliable if found to be more than 100 beats/min. Muscle tone: a very floppy baby is likely to be unconscious and in need of respira- tory support. Skin colour: a healthy baby is born blue but becomes pink within 30 seconds of effective breathing. The attendant should observe whether the baby is pink, cyanosed or pale. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 9C - 7 Effective Perinatal Care (EPC) Slide 9C-12 Apgar Score History: In 1952, Virginia Apgar proposed a scale to assess the newborn status soon after birth to evaluate the adaptation to extrauterine life. The score was named in her honour. Virginia Apgar M.D., New York, N.Y. "A proposal for a new method of evaluation of the newborn infant". Current Re- sources in Anesthesia and Analgesia – July-August,1953. 32 (4): 260–267. The Apgar score considers five easily as- sessed signs. Learning how to determine the Apgar score correctly requires good training. Apgar scoring has been used as a systematic tool to assess and document the clinical status of the newborn at the end of 1 and 5 minutes of life. Basic Newborn Resuscitation: a practical guide. World Health Organisa- tion, Geneva, 1997 Slide 9C-13 Apgar Scoring The newborn is examined for 5 signs: Pulse (heartbeat rate), Respiration (breathing), Activity (muscle tone), Grim- ace (reflex irritability) and Appearance (colour). Each of these signs is assessed by point scale from 0 to 2. The total score is the sum of these five components. A baby is considered in good health if it scores a 7 or above on the test at 1 min- ute after birth. However, an initial a low score doesn't necessarily mean that the baby is unhealthy or abnormal. The score depends not only on the severity of the newborn condition but also on other factors such as drugs given to the mother, anaesthet- ics, foetal infection, foetal anomalies and if it was premature. The second assessment at the end of 5th minutes is needed. Keep in mind that a slightly low Apgar score (especially at 1 minute) is normal for some new- borns, especially those born after a high-risk pregnancy, caesarean section, or a complicated labour and delivery. Lower Apgar scores are also seen in healthy premature babies, who usu- ally have less muscle tone than full-term newborns and who, in many cases, will require extra monitoring and breathing assistance because of their immature lungs. Basic Newborn Resuscitation: a practical guide. World Health Organisa- tion, Geneva, 1997 9C - 8 Module 9C Slide 9C-14 Is Apgar Score at 1st Min- ute an Indicator for Resuscitation? Taking an Apgar score is not a prerequi- site for beginning resuscitation. The need for resuscitation must be recognized be- fore the end of the first minute of life which is when the 1st Apgar score is taken. However, components of the score, namely respiratory rate, heart beat rate, muscle tone and colour, if assessed rapidly, can identify babies needing re- suscitation. Basic Newborn Resuscitation: a practical guide. World Health Organisation, Ge- neva, 1997 European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-15 Newborn Life Support Al- gorithm All newborns should undergo a rapid ini- tial assessment of the following 4 charac- teristics: • Was the infant born after a full- term gestation? • Is the amniotic fluid clear? • Is the infant breathing or crying? • Does the infant have good muscle tone? If the answer to all 4 of these questions is "yes," the infant does not need resuscita- tion. If the answer to any of these assessment questions is "no," there is general agreement that the infant should receive 1 or more of the following 4 categories of action in sequence: A. Initial steps in stabilization (provide warmth, position, clear airway, dry, stimulate, reposi- tion) B. Ventilation C. Chest compressions D. Administration of adrenaline and/or volume expansion. The decision to progress from one category to the next is determined by the simultaneous as- sessment of 3 vital signs: breathing, heart rate, and colour. Approximately 30 seconds is allotted to complete each step, re-evaluate, and decide whether to progress to the next step. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 9C - 9 Effective Perinatal Care (EPC) Slide 9C-16 Decision about Resuscita- tion at Birth (1) If baby is crying, or breathing well, is be- coming pink and has good muscle tone - the baby should not be separated from the mother. The infant can be dried, placed directly on the mother's chest, and covered with dry linen to maintain temperature. Observa- tion of breathing, activity, and colour should be ongoing. If the baby cries, there is no need to count its heartbeat and breathing rate: theoreti- cally, they must be normal. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-17 Decision about Resuscita- tion at Birth (2) If newborn has breathing difficulties (gasping or grunting) or breathing is ab- sent, consider the need for resuscitation. Do the following: x Cut the cord x Ensure warmth by placing the infant under a radiant heat source x Position the baby correctly x Clear the airway with a bulb or suc- tion catheter x Dry the infant and stimulate breath- ing. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 . Slide 9C-18 Position the Baby Cor- rectly and Clean the Airways Act quickly and constantly check the time using a clock with second hand. Position the baby correctly: x Place the newborn on his back with the head in a "sniffing" position to open the airway x Place a 2-cm thick towel under the baby’s shoulder. Clean the airways: x Suction is needed only if there is particulate matter or blood obstruct- ing the airway x Sequence of suctioning: First from the mouth, then from the nostrils 9C - 10 Module 9C x Perform this procedure gently and softly: no deeper than 5 cm from the lip edge and 3 cm from the nostril edge x Do not aspirate more than twice. Suction may initiate spontaneous breathing. Aggressive pharyngeal suction can delay the oc- curring of spontaneous breathing and cause laryngeal spasm and bradycardia. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-19 Drying the Baby with Warm Towels Ensures Tactile Stimula- tion Drying serves as a tactile stimulation: if after drying the baby is unable to start spontaneous breathing, perform the fol- lowing steps of resuscitation. Dry the baby with warm towels , remove wet tow- els and do not waste your time for further tactile stimulation. Drying provides suffi- cient stimulation of breathing in mildly de- pressed newborns and no further stimula- tion is appropriate. Basic Newborn Resuscitation: a practical guide. World Health Organisation, Geneva, 1997 Slide 9C-20 Decision about Resuscita- tion in Case of Meconium Stained Wa- ters It is important to immediately assess the condition of the baby after birth: breathing, heartbeat rate, muscle tonus (heartbeat count after birth is a mandatory component of assessing the baby born after discharge of meconium-stained amniotic fluid). Traditional teaching recommended that me- conium-stained infants have endotracheal intubation immediately after birth and that suction be applied to the endotracheal tube as it is withdrawn. Randomized, controlled trials have shown that this practice offers no benefit if the infant is vigorous. A vigorous infant is defined as one who has strong respiratory efforts, good muscle tone, and a heart rate >100 beats per minute. Endotracheal suctioning for infants who are not vigorous should be performed immediately after birth. If newborn has breathing difficulties, or the heart rate < 100 beats per/min, or is hypotonic – cut the cord, move the baby on the resuscitation table and provide suction through direct lar- ingoscopy or intubation tube. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resuscitation Guide- lines. Circulation. 2005;112:IY-188 – IY-195 9C - 11 Effective Perinatal Care (EPC) Today there is no evidence in favour of routine aspirating from the nose and the mouth before the birth of the shoulders and before the cord is cut in case of meconium-stained amniotic fluid in term pregnancy to prevent meconium-aspiration syndrome. Vain NE, Prudent LM, Wiswell T, et al. Oropharyngeal and nasopharyngeal suctioning of meconium stained neonates before delivery of their shoulders: multicenter, randomised trial. Lancet. 2004;364:597–602 Slide 9C-21 Consider Endotracheal In- tubation Endotracheal intubation may be indicated at several points during neonatal resusci- tation: x When tracheal suctioning for me- conium is required x If bag-mask ventilation is ineffective or prolonged x When chest compressions are per- formed x For special resuscitation circum- stances, such as congenital diaphrag- matic hernia or extremely low birth weight (<1000 g), when endotracheal administration of medications is desired. The timing of endotracheal intubation may also depend on the skill and experience of the avail- able providers. After endotracheal intubation and administration of intermittent positive pres- sure, a prompt increase in heart rate is the best indicator that the tube is in the tracheobronchial tree and providing effective ventilation. If the heart rate remains slow, incorrect tube placement is the most likely cause: check the tube placement visually. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-22 In 30 Seconds after Birth After positioning the baby correctly, clean the airways, dry the baby (tactile stimula- tion), and assess the newborn’s breathing and heart rate. The baby may start to breathe well and has HR more than 100 beats per min. In this case we should give the baby to mother and observe the baby (measure temperature, monitor skin col- our and breathing) and provide essential care (skin-to-skin contact, breastfeeding). If after the initial resuscitation steps the baby is still not breathing; or is gasping or grunting; or the heart rate is less than 100 beats per min, or cyanosis (despite administration of supplementary oxygen), start ventilation with the bag and mask. In situations where supplementary oxygen is not readily available, positive-pressure ventilation should be administered with room air. 9C - 12 Module 9C Supplementary oxygen is recommended whenever positive-pressure ventilation is indicated for resuscitation; free-flow oxygen should be administered to infants who are breathing but have central cyanosis. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Basic Newborn Resuscitation: a practical guide. World Health Organisa- tion, Geneva, 1997 Slide 9C-23 Ventilation with Bag and Mask The masks should be: x Available in 2 sizes: Size 0 for low weight newborns and Size 1 – for term newborns; x Available with soft edges. Bag should be: x A self-inflating bag for neonatal re- suscitation with volume 250-400 ml x Able to generate the pressure of at least 45 cm of water when com- pressed x Easy to assemble and disassem- ble and easy to clean. In term infants, initial inflations—either spontaneous or assisted—create a functional residual capacity. The optimum pressure, inflation time, and flow rate required to establish an effective functional residual capacity have not been determined. Average initial peak inflating pressures of 30 to 40 cm H2O (inflation time undefined) usually successfully ventilate unresponsive term infants. Assisted ventilation rates of 40 to 60 breaths per minute are commonly used, but the relative efficacy of various rates has not been investigated. Chest wall movement should be assessed when the bag is squeezed. Basic Newborn Resuscitation: a practical guide. World Health Organisa- tion, Geneva, 1997 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resuscitation Guide- lines. Circulation. 2005;112:IY-188 – IY-195 9C - 13 Effective Perinatal Care (EPC) Slide 9C-24 Positioning the Mask Gently press the mask to the face of the baby, so that it covers the chin, mouth and nose. Basic Newborn Resuscitation: a practical guide. World Health Organisation, Ge- neva, 1997 Slide 9C-25 If There Are No Chest Wall Movements during Ventilation “The primary measure of adequate initial ventilation is prompt improvement in the heart rate: Chest wall movement should be assessed if heart rate does not im- prove.” 2005 American Heart Association Guide- lines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resuscitation Guide- lines. Circulation. 2005;112:IY-188 – IY- 195 Observe the chest wall movement when the bag is squeezed. If chest wall doesn’t move the most probable obstacles are due to: x Inappropriate head position x Poor seal between the mask and the face x Insufficient ventilation x Mucus, blood, or meconium in the airway. Essential Newborn Care Course Training Manual (Draft). Geneva, World Health Organiza- tion, 2006 Basic Newborn Resuscitation: a practical guide. World Health Organisa- tion, Geneva, 1997 9C - 14 Module 9C Slide 9C-26 In the First Minute after Birth (1) After 30 seconds of ventilation with bag and mask reassess the baby’s breathing and heart rate and take appropriate ac- tion. When calculating the heart rate, you should stop ventilation for 6 second: count heart rate for 6 seconds and then multiply x 10 thus you will have HBR for 1 minute. If the baby is crying or breathing well (no gasping or grunting, no severe chest in- drawing) and has heart rate > 100 beats per min – give the baby to the mother to provide skin-to-skin contact, continue observation (skin colour, breathing, activity), control the body temperature and ensure first breastfeeding. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resuscitation Guide- lines. Circulation. 2005;112:IY-188 – IY-195 European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 At the end of 1 minute after birth the newborn must be assessed by an Apgar score. Slide 9C-27 At These Steps of Resusci- tation if the Baby is Breathing Well and if HR>100 Beats per Minute, the Baby Needs to Be with the Mother* After the initial steps of neonatal resusci- tation or after ventilation with bag and mask, the baby can be given to mother for skin-to-skin contact. In this case ensure close monitoring (breathing and tempera- ture) as well as help the baby to start breastfeeding. Pregnancy, Childbirth, Postpartum and Newborn Care: A guide for essential prac- tice. WHO, Geneva, 2006. 9C - 15 Effective Perinatal Care (EPC) Slide 9C-28 In the First Minute after Birth (2) After 30 seconds of ventilation with bag and mask reassess the baby’s breathing and heart rate and take appropriate ac- tion. If after ventilation with bag and mask, the infant remains not breathing, or gasping, or grunting or heart rate is less than 100 beats per min but more than 60 beats per min, or central cyanosis (despite admini- stration of supplementary oxygen), con- tinue ventilation with bag and mask or consider the possibility of endotracheal intubation if skilled staff is present. Chest compressions are an indicated for a heart rate is less than 60 beats per min despite ade- quate ventilation for 30 seconds. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resuscitation Guide- lines. Circulation. 2005;112:IY-188 – IY-195 European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C-29 Chest Compression Chest compression is effective only if the lungs have first been successfully in- flated. Compressions should be delivered on the lower third of the sternum to a depth of approximately one third of the anterior- posterior diameter of the chest. Chest compression should be coordi- nated with ventilation to avoid simultane- ous delivery: x There should be a 3:1 ratio of com- pressions to ventilations with 90 com- pressions and 30 breaths to achieve 120 events per minute to maximize ventilation at an achievable rate x Thus, each event will be allotted approximately ½ second, with exhalation occurring during the first compression after each ventilation. The health professional performing chest compressions, must count aloud to coordinate ventila- tion and compressions (team work). Breathing, heart rate, and colour should be reassessed every 30 seconds, and coordinated chest compressions and ventilations should continue until the spontaneous heart rate is >60 beats per min. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 9C - 16 Module 9C Slide 9C-30 Chest Compression Tech- niques There are two techniques of chest com- pression: x With 2 thumbs x With 2 fingers. European Resuscitation Council Guide- lines for Resuscitation. Section 6: Paedi- atric life support, Resuscitation of babies at birth, 2005:S115-S133 2005 American Heart Association Guide- lines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resuscitation Guide- lines. Circulation. 2005;112:IY-188 – IY-195 Slide 9C-31 The Two Thumbs Tech- nique The optimal technique is to place the two thumbs side by side over the lower third of the sternum, with fingers encircling the torso and supporting the back. Do not take the fingers off the chest dur- ing chest compression. Because the two -thumbs encircling hands technique may generate higher peak systolic and coronary perfusion pressure than the 2-finger technique, the two- thumbs encircling hands technique is recommended for performing chest compressions in newly born infants. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resusci- tation Guidelines. Circulation. 2005;112:IY-188 – IY-195 9C - 17 Effective Perinatal Care (EPC) Slide 9C-32 The Two Fingers Tech- nique The technique compression with two fin- gers with a second hand supporting the back. Do not take the fingers off the chest dur- ing chest compression. This 2-finger technique (the tip of 2nd and 3rd or 3rd and 4th fingers) may be prefer- able when access to the umbilicus is re- quired during insertion of an umbilical catheter. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 13: Neonatal Resusci- tation Guidelines. Circulation. 2005;112:IY-188 – IY-195 Slide 9C-33 In 90 Seconds after Birth (1) After 30 seconds of chest compression and ventilation with a bag and a mask, stop ventilating and chest compression and re-assess the heart rate and breath- ing rate. Once adequate ventilation and circulation are established, the infant should be maintained in or transferred to an envi- ronment in which close monitoring and anticipatory care can be provided. If the newborn does not initiate breathing or the heart rate is less than 100 beats per min but more than 60 beats per minute, stop chest compression and continue ventilation for another 30 seconds. If the newborn does not initiate spontaneous breathing, possible tracheal intubation must be considered: in this case endotracheal intubation can facilitate more effective ventilation. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 9C - 18 Module 9C Slide 9C-34 In 90 Seconds after Birth (2) If the heart rate is less than 60 beats per minute after 30 seconds of chest com- pression and ventilation, Adrenaline should be administered and chest com- pression and ventilation should be contin- ued. Use the Intravenous (IV) route as soon as venous access is established. The rec- ommended IV dose of adrenaline is 10-30 mcg/kg or 0.01 – 0.03 mg/kg per dose. Do not give high IV doses. The tracheal route is not recommended but if it is used, it is highly likely that doses of 30 mcg/kg (0.03 mg/kg) or less are ineffective: try a higher dose up to 100 mcg/kg or 0.1 mg/kg. The concentration of adrenaline for either route should be 1:10,000 (0.1 mg/mL). European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 Slide 9C- 35 If Baby Was Intubated, and/or Received Chest Compression and/or Received Adrenaline, the Baby Needs to Be Transferred for Appropri- ate Care and Monitoring *** Ensure a safe and timely transfer: explain to the family the reasons for transferring the baby, prepare the baby for transfer, communicate with the receiving facility, and provide care during transfer. If possi- ble, transfer the mother with the baby. Managing Newborn Problems: A guide for doctors, nurses, and midwives. WHO, Geneva, 2003. Slide 9C- 36 When to Consider Stop- ping Neonatal Resuscitation? It is vitally important that the team caring for the newborn informs the parents of the baby’s progress. Decision to discontinue resuscitation ideally should involve senior paediatric staff. Infants without signs of life (no heart beat and no respiratory effort) after 10 minutes of resuscitation show either a high mortal- ity or severe neurodevelopmental disabil- ity. 9C - 19 Effective Perinatal Care (EPC) After 10 minutes of continuous and adequate resuscitative efforts, discontinuation of resuscita- tion may be justified if there are no signs of life. European Resuscitation Council Guidelines for Resuscitation. Section 6: Paediatric life support, Resuscitation of babies at birth, 2005:S115-S133 The newborns who do not initiate spontaneous breathing after 20 minutes of adequate ventila- tion, has probably suffered severe asphyxia. It will probably require intensive care if it survives. If such care is available, the ventilation could be continued for 30 minutes while admission to the intensive care unit is being arranged. If such care is not available, ventilation can be discon- tinued if there is no response (no spontaneous breathing) after 20 minutes of ventilation. Basic Newborn Resuscitation: a practical guide. World Health Organisa- tion, Geneva, 1997 Slide 9C-37 Estimated Distribution of Direct Causes of 4 Million Neonatal Deaths for the Year 2000 Every year an estimated 4 million babies die in the first 4 weeks of life (neonatal period), but the majority of deaths are not reported; in many countries newborns are not registered until 1-6 weeks of life. This diagram shows the main causes for 4 million of newborn deaths in 2000 worldwide. The complications of asphyxia are the third direct cause of newborn death, and this number can be reduced by providing of effective neonatal resuscitation. In the same time many newborns with another pathology (preterm newborn, newborn with con- genital anomalies etc) can have breathing difficulties at birth, not due to asphyxia, and require neonatal resuscitation. Joy E lawn, Simon Cousens, Jelka Zupan, for the Lancet Neonatal Sur- vival Streeting Teaml. 4 million neonatal deaths: When? Where? Why? The Lancet, March 2005; 9-18 Slide 9C-38 Definition of Newborn As- phyxia Newborn asphyxia is a disease, not a symptom and it can be as a cause of neonatal resuscitation. The diagnosis “newborn asphyxia” is pos- sible only if all the four signs listed are present. x Evidence of a metabolic acidosis in foetal umbilical cord arterial 9C - 20 Module 9C blood obtained at delivery (pH <7 and base deficit 12 mmol/L) x Apgar scores of 0–3 for beyond 5 minutes x Evidence of neonatal neurologic sequelae (eg, seizures, coma, hypotonia) x Existence of one or more of the following organ or system injuries: cardiovascular, gas- trointestinal, hematologic, pulmonary, or hepatic injury or renal system dysfunction. The diagnosis “newborn asphyxia” is confirmed after receiving a laboratory test result (acidosis) and finding neurological compromises and organ and/or system lesions in 72 hours after the birth of the baby. ACOG Committee Opinion. Number 326, December 2005. Inappropriate use of the terms fetal distress and birth asphyxia. Obstet Gynecol. 2005 Dec;106(6):1469-70. Slide 9C-39 Conclusions 9C - 21 Effective Perinatal Care (EPC) Case Study: Bogdan is born after 40 weeks of gestation. Vacuum-extraction was performed. The amniotic fluid was clear. Immediately after birth the midwife put Bogdan on his mother’s chest, he was gasping. The midwife cut the cord and moved Bogdan to the table, turned the radiant heater on, dried the boy with towels, and conducted tactile stimulation along his back. Then the midwife aspirated from the nose and the mouth and assessed Bogdan (end of the first min). Bogdan was breathing irregularly at a rate of only 20 breaths per minute. When his nose and mouth were aspirated he grimaced. His heart rate was 90 beats per minute. His extremities were cyanotic and he was hypotonic. The midwife called for help. The doctor came within three minutes with a bag and a mask, re-assessed Bogdan and started ventilation. Questions: 1. Was everything done correctly in Bodgan’s case? What could have been done differently? 2. Which resuscitation equipment must be prepared for every birth? x When should the equipment have been prepared? x How was the preparation of equipment in Bogdan’s case? 3. Should Bogdan be assessed by an Apgar Score at 1 minute? Please explain? 4. What should be done for Bogdan in the following 5 minutes? 9C - 22 Effective Perinatal Care (EPC) Facilitator guide 10C - 1 Module 10ɋ Integration of Prevention of Mother to Child HIV Transmission into Effective Perinatal Care Effective Perinatal Care (EPC) 10C - 2 Module 10C 10C - 3 Slide 10C-1. Integration of Prevention of Mother to Child HIV Transmission into Effective Perinatal Care One of the main components of Effective Perinatal Care is the prevention of Mother to-Child transmission (MTCT) of HIV. This module covers activities for the prevention and transmission of HIV from infected women to their babies during pregnancy, labour and breastfeeding . Learning objectives: x Be informed on the magnitude of MTCT in the European region x Be informed about the risk of Mother to Child Transmission of HIV x Understand that PMTCT needs to be fully integrated in routine antenatal, intra partum and postpartum care x Understand that HIV-positive mothers and babies need to be treated with respect and confidentiality x Be familiar with prophylaxis ARV treatment to prevent MTCT, counselling and specific care for HIV-positive women in antenatal period x Be familiar with major obstetric scenarios for HIV-positive women at admission to maternity x Be knowledgeable about specific care for the immediate postpartum period for HIV- positive mother and newborn preventing MTCT x Be conversant with infant feeding patterns in cases of HIV-positive mother for preventing MTCT x Be trained in basic counselling skills Slide 10C-2. Adults and Children Estimated to be Living with HIV, 2007 Global data on estimated number of people (adults and children) living with HIV in the world by regions. Eastern Europe has one of the fastest growing HIV epidemics in the world especially among young people “AIDS Epidemic Update: December 2006”. UNAIDS/WHO, Geneva, 2006 Over 90% of new infections among infants occur through MTCT Effective Perinatal Care (EPC) 10C - 4 Guidance on Global Scale-up of the Prevention of Mother to Child Transmission of HIV. Towards universal access for women, infants and young children and eliminating HIV and AIDS among children. WHO, Geneva, 2007 Slide 10C-3. HIV Prevalence among Pregnant Women in Eastern Europe, 1999- 2004 These graphs show the increase of HIV prevalence (number of cases per 10,000 people) among pregnant women in the Russian Federation, Ukraine, Belarus and Georgia. Data from Georgia is available since 2004. A Nardone, J Alix, I Devaux, A Downs, G Likatavicius. HIV in Eastern Europe. EuroHIV, Institut de veille sanitaire, France, 2006 Slide 10C-4. WHO Comprehensive Approach the Prevention of HIV Infection in Infants and Young Children This comprehensive approach includes the four listed components. During this module only the third component will be considered regarding prevention of MTCT of HIV both in antenatal clinics and in maternities. Nevertheless, to be successful in preventing HIV among women, infants and young children all FOUR components of this program need to be implemented through active cooperation between governments, health care system and NGOs Guidance on Global Scale-up of the Prevention of Mother to Child Transmission of HIV. Towards universal access for women, infants and young children and eliminating HIV and AIDS among children. WHO, Geneva, 2007 Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Module 10C 10C - 5 Slide 10C-5. How Many Babies Will Be Infected? Hypothetical Group of 100 HIV Positive Mothers without PMTCT Interventions during pregnancy, labour and infant feeding Preble and Piwoz (2002) used MTCT data from scientific studies to illustrate the risks of MTCT when there are no interventions during pregnancy and labour, and if the mother was breastfeeding for 2 years. The number of infected babies born to a hypothetical group of 100 HIV-positive mothers would be: x 7 children would be infected during the pregnancy x 15 children would be infected in the labour x 15 children would be infected during the two years period of breastfeeding. But 63 children would not be infected by HIV despite the fact that they receive no special medical intervention, no ARV treatment and breastfeeding was maintained for 2 years. Elizabeth A. Preble, Ellen G. Piwoz. Prevention of mother-to-child transmission of HIV in Asia: practical guidance for programs. The LINKAGES Project, June 2002, p. 8. Slide 10C-6. Interventions to Prevent Mother – Infant HIV Transmission (by timing) The aim of improving the quality of MCH services and integrating a set of key interventions to prevent MTCT into these services is to ensure that women have greater access to high-quality antenatal, labour, delivery and postpartum care, including counselling and support for infant feeding, and use existing services more frequently and earlier in pregnancy than is currently the case. HIV testing and counselling as the pivotal component of programmes to prevent MTCT is essential for identifying women who can benefit from ART and care either immediately or later, or benefit from interventions to prevent HIV infection in their infants. For those who miss this, HIV testing and counselling for women in labour or shortly after childbirth can also facilitate their entry into PMTCT services as well as other HIV prevention, treatment and care services. Effective Perinatal Care (EPC) 10C - 6 Women living with HIV require additional services during pregnancy, labour and delivery and the postpartum period. During pregnancy, women living with HIV require either ART or ARV prophylaxis for PMTCT (depending on whether they have indications for ART), cotrimoxazole prophylaxis (if they are eligible), screening for and treatment of TB infection, counselling and care relating to nutrition and psychosocial support. MCH services need to pay particular attention to safer delivery practices and counselling and support on infant feeding for women living with HIV. In sum, programmes to prevent MTCT must be implemented and scaled up both as important prevention interventions and as access points for care, treatment and support for women living with HIV, their children and families. For this to happen, interventions to prevent MTCT need to be integrated into MCH services and programmes for HIV treatment and care. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006 Slide 10C-7. 2010 European Region Goals The regional goal refers to the WHO comprehensive 4 components PMTCT strategy These goals for the European Region are consistent with the global goals set by the United Nations General Assembly Special Session on HIV/AIDS in June 2001 - Commitment 54. Declaration of Commitment on HIV/AIDS. …“By 2005, reduce the proportion of infants infected with HIV by 20%, and by 50% by 2010, by: ensuring that 80% of pregnant women accessing antenatal care have information, counselling and other HIV prevention services available to them, increasing the availability of and by providing access for HIV-infected women and babies to effective treatment to reduce mother-to-child transmission of HIV, as well as through effective interventions for HIV-infected women, including voluntary and confidential counselling and testing, access to treatment, especially anti-retroviral therapy and, where appropriate, breast milk substitutes and the provision of a continuum of care.”… Declaration of Commitment on HIV/AIDS. “Global Crisis – Global Action”, United Nations General Assembly, Special Session on HIV/AIDS, 25-27 June 2001, New York Module 10C 10C - 7 Slide 10C-8. Respect and Confidentiality Are Needed for Each HIV-Positive Woman/Mother and Their Baby “HIV/AIDS is not only one of the greatest health challenges of our time, but it is also our greatest human rights challenge. Those aware they are HIV-infected shoulder the twin burdens of stigma and discrimination. Fear of becoming infected underlies stigma and discrimination, which remain major impediments to preventing HIV transmission and providing treatment, care, and support to people who are HIV-infected and their families.” “Freedom from discrimination is a fundamental human right founded on principles of natural justice that should be universally applied to people everywhere. According to recent United Nations Commission on Human Rights resolutions, "discrimination on the basis of HIV/AIDS status, actual or presumed, is prohibited by existing human rights standards." In other words, discrimination against PLWHA or people thought to be infected is a clear violation of human rights.” Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-9. HIV-Positive Mothers and Babies Need to Be Treated as Other Mothers and Babies with Love and Respect, and Benefit from the Evidence Based Perinatal Care This is a letter from an HIV- positive mother to the staff of the maternity where she delivered. This letter demonstrates that HIV-positive mothers can be treated with respect and receive the best of medical care. This demonstrates how changes in attitudes and practices of healthcare workers can positively affect the lives of HIV- positive mothers and children. Effective Perinatal Care (EPC) 10C - 8 Slide 10C-10. Core Interventions for PMTCT during Antenatal Period Listed here are the key interventions to reduce MTCT during the antenatal period Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-11. 1. Provide Appropriate Information and HIV Testing to Each Pregnant Woman and Support Partner Involvement All women receiving antenatal care should be counselled and offered HIV testing. Provide appropriate pre and post test counselling on HIV testing for all women regardless of their HIV status helps prevent MTCT as well as prevent HIV among women and their sexual partners. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Guidance on Provider-initiated HIV testing and counselling in health facilities. WHO/UNAIDS, 2007 Slide 10C-12. Core Interventions for PMTCT during Antenatal Period In addition to HIV testing it is important to provide special care and support to each HIV-positive pregnant woman. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Module 10C 10C - 9 Slide 10C-13. 2. Ensure an Essential Package of Integrated Antenatal Care Services An HIV-positive woman should make her own decisions about her pregnancy after receiving comprehensive and evidence based information on the risk of MTCT. Involvement of peer-counsellors is essential to provide psychological and social support to all HIV-positive women. Medical care and support to HIV-positive pregnant women requires a multidisciplinary approach. HIV-positive pregnant women need to receive appropriate care and additional information and counselling about MTCT prevention: – Staging of HIV disease; ARV prophylaxis or therapy – Counselling on safest mode for birth – Counselling on safest infant feeding After confirming a woman’s HIV-positive status she should be evaluated on the clinical and immunological status of her HIV/AIDS infection. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-14. Core Interventions for PMTCT during Antenatal Period The 3rd intervention during the antenatal period is the prescription of antiretroviral drugs for HIV-positive pregnant women. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004. Effective Perinatal Care (EPC) 10C - 10 Slide 10C-15. 3. Provide ART or prophylactic ARV to prevent MTCT ARV prophylaxis: Short-term use of antiretroviral drugs to reduce HIV transmission from mother to infant. Antiretroviral prophylaxis does not treat maternal HIV or provide long- term protection for the infant. ARV treatment: Long-term use of antiretroviral drugs to treat maternal HIV/AIDS and prevent PMTCT. Antiretroviral treatment during pregnancy can improve a woman’s health and decrease HIV transmission risk to the infant by reducing the maternal viral load. ARV drugs are effective for both treating maternal HIV infection and preventing MTCT. Several antiretroviral regimens reduce the risk of MTCT in both breastfeeding and non- breastfeeding women. The mechanisms by which these regimens prevent or reduce mother-to-child HIV transmission include decreasing viral replication in the mother, leading to a decrease in viral load in the infant and/or prophylaxis during and after exposure to the virus. Based on women health status and availability of ARV medications she could be administered during pregnancy several ARV regimens. • The first choice prophylaxis ART regimen for PMTCT: Zidovudine (AZT or ZDV) started from 24-28 weeks of pregnancy or as soon as possible thereafter. The regiment could also be used if HAART is not available. • WHO recommendations on longer prophylaxis regimens: until recently, the emphasis of PMTCT guidelines has been on short-course prophylaxis (e.g. short- course Zidovudine or short-course Nevirapine in resource-constrained settings). New recommendations from WHO (2004) emphasize longer, combination prophylaxis regimens, where feasible, while recognising the need for short-course prophylaxis where longer regimens have not been provided or are not feasible. For women diagnosed with HIV during pregnancy and eligible for treatment with ARVs, treatment should be initiated as soon as possible. The start of treatment may be delayed until after the first trimester. However, when the woman is severely ill, the benefits of treatment outweigh any potential risk to the foetus. Highly Active Antiretroviral Treatment (HAART) a combination of 3 drugs is the core intervention for treatment of advanced HIV disease or AIDS case. HAART is also the most effective prophylaxis for mother-to-child transmission. The most common drug combinations used as HAART during pregnancy are: • Zidovudine/Lamivudine/Nevirapine or Zidovudine/Lamivudine/Nelfinavir • Zidovudine/Lamivudine/Saquinovir with Ritornavir. If women received HAART during pregnancy due to advanced HIV disease stage/AIDS she should continue to take the same regimen after delivery. If women received HAART during pregnancy not because of poor health status but only for prevention of MTCT, she should stop taken ARV drugs after the labour. Module 10C 10C - 11 Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006 Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 10 Prevention of HIV Transmission from HIV Infected Mothers to their Infants. Clinical Protocol for the WHO European Region. World Health Organization, Regional Office for Europe, Copenhagen, 2006 Slide 10C-16. Core Interventions for PMTCT in Maternity The first intervention at admission to the maternity is the assessment of maternal HIV status in labour, if HIV status unknown pre-test and rapid HIV test should be done. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-17. In Maternity Main reasons preventing HIV+ women to seek for medical care is the fear of the HIV+ status and stigmatization and discrimination towards them and their children. Medical care providers should be convinced to respect the confidentiality and privacy of each woman including HIV+ mother and their baby and do all their best to fight against stigma and discrimination in their maternity. Confidentiality is the first of the three guiding principles for testing and counselling in PMTCT settings (the other guiding principles are informed consent and post-test support and services). Confidentiality is important for establishing patient trust. This trust is central to the decision to consent to testing. As such, confidentiality is one of the keys to ensuring a successful PMTCT programme. Effective Perinatal Care (EPC) 10C - 12 Maintaining confidentiality is an important responsibility of all healthcare workers and is essential to establishing patient trust. Information that is shared between healthcare workers and patients must be kept private. It is essential that a private venue/room be used for all discussions of HIV-related matters, particularly HIV diagnosis. Patients should be informed that personal and medical information, including HIV test results, may be disclosed to other healthcare providers to ensure that they receive appropriate medical care. Healthcare workers should emphasize, however, that only those healthcare workers who are directly involved in the patient's care will have access to the patient’s records— and only on a “need-to-know” basis. All medical records and registers, whether or not they include HIV-related information, should be kept confidential and stored in a safe, secure place. Each maternity staff needs to respect the rules of confidentiality everywhere providing care for women and their children: x Do not isolate HIV+ women into special department or room x Don’t mark HIV+ patients files to be recognized easily in the maternity x Never disclose HIV positive status x Provided to HIV+ women and their children same level of care as non HIV infected women x Implemented rooming-in and free visiting of relatives and friends for all women including HIV+ mother. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-18. 1. Assessment of Maternal HIV Status at Admission to the Maternity If HIV status is unknown, a maternity staff member should conduct appropriate pre and post test counselling on HIV and recommend a HIV rapid test. An HIV rapid test should be used only after the woman is admitted and when she agrees to the test. Maternity staff should be trained on counselling and testing and the maternity should be equipped with HIV rapid tests. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Module 10C 10C - 13 Slide 10C-19. Core Interventions for PMTCT in Maternity Here are listed the key interventions on PMTCT. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-20. 2. Choice of Delivery Method if the Woman Is Admitted to Maternity with a Known HIV-Positive Status The decision regarding the mode of delivery rests with the woman and her clinician, who should inform her of the potential risks and benefits. Results from a large meta- analysis of 15 prospective cohort studies in North America and Europe involving 8,533 mother- infant pairs: After adjustment for receipt of antiretroviral therapy, maternal stage of disease, and infant birth weight, the likelihood of vertical transmission of HIV-1 was decreased by approximately 50 percent with elective caesarean section, as compared with other modes of delivery (adjusted odds ratio 0.43; 95 percent confidence interval, 0.33 to 0.56). The results were similar when the study population was limited to those with rupture of membranes shortly before delivery. The likelihood of transmission was reduced by approximately 87 percent with both elective caesarean section and receipt of antiretroviral therapy during the prenatal, intrapartum, and neonatal periods, as compared with other modes of delivery and the absence of therapy (adjusted odds ratio 0.13; 95 percent confidence interval, 0.09 to 0.19). Among mother– child pairs receiving antiretroviral therapy during the prenatal, intrapartum, and neonatal periods, rates of vertical transmission were 2.0 percent among the 196 mothers who underwent elective caesarean section and 7.3 percent among the 1255 mothers with other modes of delivery. The results of this meta-analysis reported a 50% reduction in the transmission rate in women who underwent an elective caesarean section before the onset of labour or rupture of the membranes. This protective effect persisted when anti-retroviral therapy was used. The European Mode of Delivery Collaboration. Elective caesarean section versus vaginal delivery in preventing vertical Effective Perinatal Care (EPC) 10C - 14 HIV transmission: a randomised clinical trial. Lancet, 1999, 353, 1035-1037. The International Perinatal HIV Group. The mode of delivery and the risk of vertical transmission of human immunodeficiency virus type 1: a meta- analysis of 15 prospective cohort studies. N Engl J Med, 1999, 340, 977–87. Royal College of Obstetricians and Gynecologists (RCOG). MANAGEMENT OF HIV IN PREGNANCY. RCOG Press, April 2004, Guideline No. 39. Slide 10C-21. 2. Choice of Delivery Method if the Woman Is Admitted to Maternity with Unknown HIV-Status It is recommended that delivery by elective caesarean section should be timed to take place after 38 weeks of gestation. This timing reflects the need to balance the risk of respiratory complications in the neonate with the risk of perinatal HIV transmission associated with labour. Effectiveness of Caesarean section in PMTCT is higher if it is performed prior to membrane rupture and before onset of labour. If the labour is too advanced (uterus contractions or more than 4 hours after rapture of membranes) an “elective” C-section could not be performed as it will not have any significant impact on MTCT. Decision on delivery method should be made based on assessment of potential risks and benefits and woman’s informed consent. Should also be taken into consideration the intrapartum risk factors for MTCT: x Pelvic inflammatory diseases [A] x Severity of maternal HIV disease [A] x High viral load [A] The European Mode of Delivery Collaboration. Elective caesarean section versus vaginal delivery in preventing vertical HIV transmission: a randomised clinical trial. Lancet, 1999, 353, 1035-1037. The International Perinatal HIV Group. The mode of delivery and the risk of vertical transmission of human immunodeficiency virus type 1: a meta- analysis of 15 prospective cohort studies. N Engl J Med, 1999, 340, 977–87. Royal College of Obstetricians and Gynecologists (RCOG). MANAGEMENT OF HIV IN PREGNANCY. RCOG Press, April 2004, Guideline No. 39. Module 10C 10C - 15 Slide 10C-22. Core Interventions for PMTCT in Maternity Here are listed the key interventions on PMTCT. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-23. 3. Elective Caesarean Section Could Reduce MTCT by 50% Women who are HIV positive who have a detectable plasma viral load and/or who are NOT taking HAART should be offered a planned caesarean section as it reduces the risk of mother-to-child transmission of HIV. [A] Decision about operation should be made after woman’s counselling on all potential risks and benefits for her and her child. The European Mode of Delivery Collaboration. Elective caesarean section versus vaginal delivery in preventing vertical HIV transmission: a randomised clinical trial. Lancet, 1999, 353, 1035-1037. The International Perinatal HIV Group. The mode of delivery and the risk of vertical transmission of human immunodeficiency virus type 1: a meta- analysis of 15 prospective cohort studies. N Engl J Med, 1999, 340, 977–87. Royal College of Obstetricians and Gynecologists (RCOG). MANAGEMENT OF HIV IN PREGNANCY. RCOG Press, April 2004, Guideline No. 39. Effective Perinatal Care (EPC) 10C - 16 Slide 10C-24. Core Interventions for PMTCT in Maternity Here are listed the key interventions on PMTCT. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-25. 4. Safe Vaginal Delivery Practices Strictly monitor the labour and birth using a partograph and implement interventions which can reduce MTCT: Minimise cervical examinations: x Perform cervical examinations only when absolutely necessary and with appropriate clean technique. Avoid prolonged labour: x Consider using oxytocin to shorten labour when appropriate. x Use non invasive foetal monitoring to assess need for early intervention. Avoid routine rupture of membranes: x Avoid artificial rupture of membranes, unless necessary. Avoid unnecessary trauma during labour and birth thus promote free choice of position by the mother: x Avoid invasive procedures, including scalp electrodes or scalp sampling. x Avoid routine episiotomy. x Minimise the use of forceps or vacuum extractors. Minimise the risk of postpartum haemorrhage: x By implementation of active management of the third stage of labour. Repair genital tract lacerations. Use Universal Precautions to prevent infection both to woman and staff: x Use universal precautions, which include the use of protective gear, safe use and disposal of sharp items, sterilisation of equipment, and safe disposal of contaminated materials. Module 10C 10C - 17 Use safe transfusion practices: x Minimise the use of blood transfusions. Use only blood screened for HIV and when available, syphilis, malaria, and hepatitis B and C. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-26. Core Interventions for PMTCT in Maternity Here are listed the key interventions on PMTCT. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-27. 5. Use of Antiretroviral Drug in Labour/Elective Caesarean Section If HIV positive women come to the maternity to deliver or to have an elective CS, she should receive the same ARV regimen as she has received during her pregnancy. 1. Woman treated by ZDV during the pregnancy: - If vaginal delivery she should received at the onset of the labour ZDV 300 mg + Nevirapine NVP 200 mg, and then ZDV each 3 hours or one dose of 600 mg ZDV - If C-section only one dose of ZDV. If she has received only ZDV she should received one dose of Nevirapine (NVP) at the onset of the labour and not later then 2 hours prior to the C-section CS. 2. If HIV status was detected only in labour then women should administered one dose on NVP as soon as possible. - All women treated by NVP during the labour need to received ZDV/Lamivudine combination for 1 week postpartum to prevent the emergence of HIV resistance to NVP. Effective Perinatal Care (EPC) 10C - 18 3. If women received HAART during pregnancy due to advanced HIV disease stage she should continue to take the same regimen after delivery. If women received HAART during pregnancy for prevention of MTCT, she should stop taken ARV drugs after the labour. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006 HIV/AIDS Treatment and Care. WHO protocols for CIS Countries. Version 1. WHO EURO, Copenhagen, 2004 Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 10 Prevention of HIV Transmission from HIV Infected Mothers to their Infants. Clinical Protocol for the WHO European Region. World Health Organization, Regional Office for Europe, Copenhagen, 2006 Slide 10C-28. Core Interventions for PMTCT in Maternity Listed here are the key interventions on PMTCT. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-29. 6. Safe Infant Feeding Practices HIV is present in breast milk of HIV+ woman, so HIV can be transmitted to the infant during the period of breastfeeding. The risk of MTCT increases with prolongation of breastfeeding period up to 5-10% at two years period of breastfeeding. Mixed feeding increased risk of MTCT up to 20% compare to feeding replacement. Module 10C 10C - 19 Elizabeth A. Preble, Ellen G. Piwoz. Prevention of mother-to-child transmission of HIV in Asia: Practical guidance for programs. The LINKAGES Project, June 2002, p. 8. Slide 10C-30. 6. Safe Infant Feeding Practices – HIV Transmission Risk and Feeding Mode Influence of type of feeding on MTCT: x Risk of MTCT doesn’t differ until 6 month age on breastfeeding and replacement breastfeeding x Mixed feeding has highest risk of MTCT x The period of breastfeeding is longer the risk of MTCT is higher. In August 1999 ground-breaking research by Anna Coutsoudis and her team in South Africa was published. Her research, a prospective cohort study, found that those mothers who exclusively breastfed their infants had no higher rates of transmission than those infants who were artificially fed. This was crucial as it was the first time researchers had looked at the effect of exclusive breastfeeding. Previous studies had used the term breastfeeding to mean mothers who mainly breastfed but may also have used water, teas, other milks and foods. Coutsoudis (along with other researchers) found that mixed feeding, ie partial breastfeeding and the inclusion of other substances in the infants diet, gave rise to the highest rates of transmission. As Coutsoudis noted, the reason for the protective effect of exclusive breastfeeding, and the increased rates in mixed fed infants may be due to "ingestion of contaminated water, fluids, and food may lead to gut mucosal injury and disruption of immune barriers". Prior to this new research it was estimated that approximately 15% of infants of HIV positive mothers were at risk of contracting HIV through breastfeeding ; so, even in an area with a relatively high HIV prevalence of 20%, within a population of 100 mothers and infants only 2 or 3 will be at risk of contracting HIV through breastfeeding. 97 will not. If these women exclusively breastfed this rate would be even lower. In February 2001 the results of Coutsoudis's follow up study were published. This clearly showed that "infants exclusively breastfed for 3 months or more had no excess risk of HIV infection over 6 months than those never breastfed". There is an urgent need for more research (independent of company interests) to look at the effect of exclusive breastfeeding. If Coutsoudis's findings are replicated, then the consequences for all are enormous. Even now policy makers should re-examine policies which advocate artificial feeding, especially in resource poor settings, and see if instead support can be given for exclusive breastfeeding. In settings where breastfeeding is already the norm it is surely easier to continue to promote breastfeeding but with an emphasis on exclusive breastfeeding, rather than to re- educate whole populations about artificial feeding, especially if it is to be exclusive. Effective Perinatal Care (EPC) 10C - 20 Coutsoudis A. et al. “Influence of infant-feeding patterns on early mother-to-child transmission of HIV-1 in Durban, South Africa: a prospective cohort study.” The Lancet, 1999, 354, 471-476. Available on http://www.thelancet.com/ Coutsoudis A. et al. “Method of feeding and transmission of HIV- 1 from mos to children by 15 months of age: prospective cohort study from Durban, South Africa.” AIDS, 2001, 15, 379-387. Haider, R., et al. “Effects of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised, controlled trial.” The Lancet, 2000, 356, 1643-1647. Slide 10C-31. 6. Safe Infant Feeding Practices Acceptable: The mother perceives no significant barrier(s) such as cultural or social reasons for fear of stigma and discrimination in terms of choosing a feeding option. Feasible: The mother and/or family have adequate time, knowledge, skills, and other resources to prepare feeds and to feed the infant, as well as the support to cope with family, community, and social pressures. Affordable: The mother and family, with available community and/or health system support, can pay for the costs of the replacement feeding - including all ingredients, fuel and clean water - without compromising the family's health and nutrition spending. Sustainable: The mother and family has access to a continuous and uninterrupted supply of all ingredients and products needed to implement the feeding option safely for as long as the infant needs (for at least 6 months). Safe: Replacement foods are correctly and hygienically stored, prepared, and fed in nutritionally adequate quantities; infants are fed with clean hands using clean utensils, preferably by cups. Otherwise, exclusive breastfeeding is recommended during the first months of life. To minimise the risk of HIV transmission, HIV-positive mothers should discontinue breastfeeding as soon as feasible, taking into account local circumstances, the individual woman’s situation, and the risk of replacement feeding (which include malnutrition and infections other than HIV). Whatever choice a mother makes she should be supported on her choice. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Module 10C 10C - 21 Slide 10C-32. 6. Safe Infant Feeding Practice: Counselling of HIV-Positive Women on Infant Feeding Each HIV-positive mother should receive counselling which includes general information about the risks and benefits of infant-feeding options and specific guidance on selecting the option most likely to be suitable to her specific situation. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-33. Steps on Counselling HIV-Positive Mothers on Infant Feeding Infant feeding counselling, education, and support: • Includes information on various feeding options, including the advantages and disadvantages of each • Provides women with the skills needed to safely feed their infants • Includes demonstrations and opportunities for practice, raise mother for what she is doing well and repeat simple advices • Encourage partner or family involvement in infant-feeding decisions • It is important to continue counselling on child nutrition (through at least 5 years). Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Effective Perinatal Care (EPC) 10C - 22 Slide 10C-34. Core Interventions for PMTCT in Maternity Listed here are the key interventions on PMTCT. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-35. 7. ARV Prophylaxis for Infants Born to HIV-Positive Mothers If mother received ARV or HAART during pregnancy the infant should start ARV prophylaxis after delivery with ZDV syrup. It should be administered at least for the 1 week. If the duration of maternal ARV during pregnancy was less then 4 weeks, the duration of infant ZDVT course should be extended to 4 weeks and the baby needs to receive NVP at birth. If the woman was treated during pregnancy but delivers virginally the newborn needs to receive in addition to ZDV one dose of NVP at birth. If a woman was not treated during pregnancy or received NVP less than 2 hours before birth the infant should received 2 doses of NVP suspension one at birth and a second dose after 72 hours. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006 HIV/AIDS Treatment and Care. WHO protocols for CIS Countries. Version 1. WHO EURO, Copenhagen, 2004 Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 10 Prevention of HIV Transmission from HIV Infected Mothers to their Infants. Clinical Protocol for the WHO European Region. World Health Organization, Regional Office for Europe, Copenhagen, 2006 Module 10C 10C - 23 Slide 10C-36. 7. Counselling HIV-Positive Mother on Infant Care PMTCT interventions reduce, but do not eliminate, the risk of HIV transmission from mother to infant. HIV-positive mothers should receive information on infant care and development and on the necessity of regular follow ups to identify early signs of disease. Identification of infant HIV status is possible 2 days after birth, but local and regional availability of testing may differ. PCR tests (even negative) need to be repeated at age 6 weeks and 3 months. After this period, if PCR is negative it is certain that the baby is not HIV-positive (although baby can be sero-convert as a result of breastfeeding). Negative status can be confirmed by Elisa test at the age of 18 months. Each mother should be informed as to when her baby should be tested with HIV by HIV PCR and ELISA tests. Mothers should be informed how to prevent Pneumocistic carinii pneumonia infection with Cotrimoxazole syrup starting at 4 weeks of age and continuing until identification of the HIV-negative status. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-37. Core Interventions for PMTCT in Maternity Listed here are the key interventions on prevention of mother to child transmission of HIV. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Effective Perinatal Care (EPC) 10C - 24 Slide10C-38. 8. Prevention and Treatment of Post Partum Co- Morbidities If an elective caesarean section is done, carefully prevent infection using an appropriate course of antibiotics. Sexual transmitted infections are often associated with HIV, thus women with symptoms of STIs or other diseases should receive appropriate treatment. If a woman has received HAART before and/or during pregnancy or she is getting other treatment prescribed by an HIV/AIDS specialist, she should continue her treatment. The substitution treatment will be discussed and implemented together with the drug addictions specialist. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-39. Core Interventions for PMTCT in Maternity Listed here are the key interventions on prevention of mother to child transmission of HIV. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Module 10C 10C - 25 Slide 10C-40. 9. Appropriate Postpartum Counselling on Family Planning for HIV-Positive Mothers Prevention of unwanted pregnancies of HIV-positive women is a key intervention in PMTCT. The postpartum period is an ideal time to counsel HIV-positive women on family planning. Condom use should be promoted by health workers to all HIV-positive women as a family planning method and protection from STIs, hepatitis B and HIV. The effectiveness of family planning counselling is higher if a woman’s partner is involved, thus health workers should use all opportunities to counsel family pairs on family planning during the postpartum period. Recommendations for counselling on family planning and sexual health: • Discuss condom use as dual protection (against STIs, including HIV, and for family planning) • Support the mother's choice of contraceptive method • Discuss the importance of safe sex to prevent the spread of HIV and other STIs • Provide advice regarding early STI treatment, including symptom recognition and where to go for STI assessment and treatment • Answer any questions the woman may have about safer sex behaviours. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Slide 10C-41. 9. Appropriate Postpartum Counselling on Referrals Needed by HIV- Positive Women The postpartum period is an ideal time to link a woman who is HIV- infected to comprehensive care that will support her health, prevent complications, and improve her ability to live with HIV. A range of related services should be provided directly or by referral, including those listed below: • Prevention and treatment of opportunistic infections • ARV treatment when indicated and available • Treatment of symptoms and palliative care • Harm reduction program for drug addicted women Effective Perinatal Care (EPC) 10C - 26 • Social and psychosocial support • Faith-based support • Home-based care. Prevention of Mother-to-Child Transmission of HIV Infection. Generic Training Package. WHO/CDC, Geneva, 2004 Module 10C 10C - 27 GENERAL RECOMMENDATIONS Care to pregnant women should include the following interventions on PMTCT: x For all pregnant women 1. Routine offer of HIV testing and counselling using rapid tests (Consider retesting of HIV-negative women late in pregnancy where feasible) 2. Infant feeding 3. Birth planning, including on skilled birth attendance 4. Syphilis screening and management of STIs. x Additional package of services for HIV-positive women 1. ARV prophylaxis for PMTCT 2. Clinical evaluation, including clinical staging of HIV disease 3. Immunologic assessment (CD4 cell count) and viral load where available 4. ART for women with indications for treatment 5. Safe elective C-section should be recommended 6. Infant feeding counselling 7. Post partum hospitalisation is a time place to inform HIV+ women about family planning, care for children and, to provide psychological support 8. Cotrimoxazole prophylaxis 9. TB screening, INH prophylaxis and treatment 10. Supportive care, including adherence support 11. Respect of the rights of each woman including HIV + women (privacy, confidentiality, individual choice about pregnancy). x Additional package of services for women in specific settings 1. Counselling, psychosocial support and referral for women who are at risk of or have experienced violence 2. Counselling and referral for women with history of harmful alcohol or drug use 3. Deworming 4. Consider retesting late in pregnancy where feasible. x Package of services for HIV-exposed infants and young children 1. Routine newborn and infant care (including routine immunisation and growth monitoring) 2. ARV prophylaxis 3. Cotrimoxazole prophylaxis 4. Early testing and diagnosis of HIV. 10 Prevention of HIV Transmission from HIV Infected Mothers to their Infants. Clinical Protocol for the WHO European Region. World Health Organization, Regional Office for Europe, Copenhagen, 2006 Effective Perinatal Care (EPC) 10C - 28 Attachment 3 SUMMARY RECOMMENDATIONS WHO Clinical Stage 1 Asymptomatic WHO Clinical Stage 2 Mild Disease WHO Clinical Stage 3 Advanced Disease WHO Clinical Stage 4 Severe Disease (AIDS) Symptoms No symptoms or only: i Persistent generalized lymphadenopathy i Weight loss 5- 10%* i Sores or cracks around lips (angular cheilitis) i Itching rash (seborrhoea or prurigo) i Herpes zoster i Recurrent upper respiratory infections such as sinusitis or otitis i Recurrent mouth ulcers i Weight loss > 10%* i Oral thrush (or hairy leukoplakia) i More than 1 month: Diarrhoea or Unexplained fever i Severe bacterial infections (pneumonia, muscle infection, etc) i Pulmonary TB i TB lymphadenopathy i Acute necrotizing ulcerative gingivitis/ periodontitis * Conditions marked with an asterisk require a clinical diagnosis – this can be from records of a previous hospitalization. Muscle infection, Pneumocystis or any other severe pneumonia, toxoplasma, cryptococcal meningitis, and Extrapulmonary TB, etc are all infections which should be referred for hospital diagnosis and treatment. i HIV wasting syndrome i Oesophageal thrush i More than 1 month: Herpes simplex ulcerations i Recurrent severe pneumonia within 6 months i Lymphoma* i Kaposi sarcoma i Invasive cervical cancer* i CMV retinitis* i Pneumocystis pneumonia i Extrapulmonary TB* i Toxoplasma* i Cryptococcal meningitis* i Visceral leishmaniasis* i HIV encephalopathy (Significant neurological impairment interfering with independent functioning and not due to other cause will often improve on ARV treatment) Prophylaxis i Cotrimoxazole prophylaxis i INH prophylaxis i Cotrimoxazole prophylaxis i INH prophylaxis i Other prophylaxis in Treatment Plan i Cotrimoxazole prophylaxis i INH prophylaxis i Other prophylaxis in Treatment Plan Module 10C 10C - 29 ARV therapy i Only if CD4 < 200 i Consider ART if CD4 between 200-350 i Only if CD4 < 200 or TLC < 1200/mm3 i Consider ART if CD4 between 200- 350 i Give ART: If CD4 not available If CD4 < 200 If pregnant or pulmonary TB or severe bacterial infection and CD4 < 350 i In other patients, consider ART if CD4 200-350 and initiate ART before CD4 count drops below 200. i All in Stage 4 are medically eligible. Treat. i Evaluate for ART i Prepare for adherence WHO Adolescent and Adult HIV Clinical Staging CD4 count: Pregnant women who test HIV-positive need to have their CD4 count checked rapidly, if possible on the same day as receiving their test result. If the number of CD4 tests which can be done by the laboratory are limited, priority should be given to pregnant women in WHO clinical stage 1 and 2, in order to decide whether to start ART or provide ARV prophylaxis. Pregnant women in stage 4 are automatically eligible for ART, irrespective of their CD4 count result. If CD4 is not available, all women in stage 3 or 4 are medically eligible for ART. The absence of CD4 count should not delay ART for pregnant women in stage 3 or 4. Some pregnant women may delay getting a CD4 count or HIV care and treatment because there is delay in obtaining the result, or the woman is overwhelmed by the implications of a positive HIV test and might need more time to consider ART. It is important to counsel all pregnant women with a positive test result and educate health workers (including laboratory personnel) on the advantages and the urgency of PMTCT interventions. Haemoglobin: In patients with pre-existing anaemia, AZT has been shown to worsen the condition. Therefore, if the proposed ARV regimen for an HIV-positive pregnant woman contains AZT, it is important to check her haemoglobin level before initiation of AZT and again at 4, 8 and 12 weeks after initiation for monitoring purposes. Haemoglobin testing should always be available at the point of care. If the woman’s haemoglobin is less than 7 g/dl before initiation, do not start AZT – instead treat the anaemia. Similarly, if the haemoglobin level falls to below 7 g/dl once the woman is started on AZT, AZT should be stopped and treat the anaemia. If the woman is receiving ART that includes AZT, replace AZT by d4T. If she is on AZT prophylaxis, stop the AZT. In both cases, treat the anaemia and reassess the woman. Effective Perinatal Care (EPC) 10C - 30 STAGES AND RECOMMENDATIONS FOR INITIATING ANTIRETROVIRAL TREATMENT IN PREGNANT WOMEN BASED ON CLINICAL STAGE AND AVAILABILITY OF IMMUNOLOGICAL MARKERS WHO Clinical Stage CD4 testing not available CD4 testing not available 1 Do not treat (Level A-III recommendations) 2 Do not treat (Level B-III recommendations) Treat if CD4 cell count <200 cells/mm3 (Level A-III recommendations) 3 Treat (Level A-III recommendations) Treat if CD4 cell count <350 cells/mm3 (Level A-III recommendations) 4 Treat (Level A-III recommendations) Treat irrespectively of CD4 cell count (Level A-III recommendations) * - Women have lower CD4 cell count during pregnancy compared to postpartum, partly due to pregnancy-related haemodilution. The impact of this on using the CD4 350 threshold in pregnant women, especially in those in clinical stage 1 or 2, is not known. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006, p.17 Module 10C 10C - 31 RECOMMENDATIONS FIRST-LINE ARV REGIMENS FOR TREATING PREGNANT WOMEN AND PROPHYLACTIC REGIMEN FOR INFANTS Mother Antepartum Intrapartum Postpartum AZT + 3TC + NVP twice dailya AZT + 3TC + NVP twice daily AZT + 3TC + NVP twice daily Infant AZT x 7 daysb a – When NVP therapy is started, NVP should be given in half of the daily dose once a day for 14 days (e.g. 200 mg once daily), with escalation to standard twice the daily dose (e.g. 200 mg twice daily) after 14 days if there are no side-effects. b – If the mother receives less than four weeks of ART during pregnancy, then four weeks, instead of one week, of infant AZT is recommended. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006, p.22 Effective Perinatal Care (EPC) 10C - 32 RECOMMENDED PROPHYLACTIC ARV REGIMENS FOR PREGNANT WOMEN WHO ARE NOT YET ELIGIBLE FOR ART AND PROPHYLACTIC REGIMEN FOR INFANTS Mother Antepartum Intrapartum Postpartum AZT starting of 28 weeks of pregnancy or as soon as feasible thereafter Sd-NVPa + AZT/3TCa AZT/3TC x 7 daysa Infant Sd-NVP + AZT x 7 daysb a – If the women receives at least four weeks of AZT during pregnancy, omission of the NVP dose may be considered for her. In this case, the NVP dose for the infant must be given immediately at birth, and four weeks instead of one week of AZT is recommended for the infant. If the NVP dose is not given to the mother, she will not require intrapartum 3TC as well as postpartum AZT and 3TC. b – If the mother receives less than four weeks of AZT during pregnancy, four weeks, instead of one week, of AZT is recommended for the infant. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006, p.27 Module 10C 10C - 33 Attachment 4 DOSES OF ANTIRETROVIRAL PROPHYLAXIS DRUGS FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV ARV regimens to be followed for women during labour and after childbirth ARV drugs during labour Give extra adherence support during labour Mother on ART during antenatal care: Continue regular schedule of ARV drugs every 12 hours (no additional ARV prophylaxis) Mother on ARV prophylaxis or not on ARV prophylaxis during pregnancy: At the onset of labour: AZT 600 mg (two tablets of 300 mg) once. Note that the woman may have already taken this dose at home - ask her and record the results. If she has taken this dose at home, administer NVP and 3TC. Plus NVP 200 mg as a single dose (not necessary to give this if the woman was on AZT for >4 weeks ) Plus 3TC 150 mg Then continue with 3TC 150 mg every 12 hours until delivery ARV drugs to mother after childbirth Mother on ART during antenatal care: Continue regular schedule of ART every 12 hours Mother on ARV prophylaxis or not on ARV prophylaxis during antenatal care: 3TC 150 mg and AZT 300 mg — twice daily for 7 days Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006, p.41-43 Effective Perinatal Care (EPC) 10C - 34 Attachment 5 ARV PROPHYLAXIS REGIMENS FOR INFANTS All infants born to HIV-infected women need to receive a course of ARV drugs as post- exposure prophylaxis. The ARV regimen for newborns will depend upon if and for how long the mother received either ART or ARV prophylaxis during pregnancy. Newborn: give ARV prophylaxis as soon after birth as possible. Duration depends on if and how long the mother took AZT prophylaxis or ART Mother’s antenatal ARV regimen Newborn ARV prophylaxis regimen >4 weeks AZT prophylaxis Single dose NVP plus AZT for 1 week 4 weeks AZT prophylaxis or no ARV prophylaxis or ART Single dose NVP plus AZT for 4 weeks >4 weeks ART AZT for 1 week 4 weeks ART AZT for 4 weeks Dosages for ARV prophylaxis for the newborn AZT 4 mg/kg twice daily NVP 2mg/kg as soon as possible after the birth ARV drugs formulation for the newborn AZT 10 mg/ml NVP 10 mg/ml Note: If the capacity to deliver combination ARV prophylaxis (NVP plus AZT) does not exist, give single dose NVP to mother and newborn. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach. WHO, Geneva, 2006, p.40-43 Module 10C 10C - 35 Attachment 6 HIV TESTING FOR THE HIV EXPOSED CHILD Encourage HIV testing for: x All children born to an HIV positive mother x All sick children with symptomatic suspected HIV infection For children >18 months, a positive HIV antibody test result means the child is infected For HIV exposed children <18 months of age: x If PCR or other virological test is available, test from 6 weeks of age ¾ A positive result means the child is infected ¾ A negative result means the child is not infected, but could become infected if they are still breastfeeding x If PCR or other virological test is not available, use HIV antibody test ¾ A positive result is consistent with the fact that the child has been exposed for HIV, but does not tell us if the child is definitely infected ¾ A negative test usually means the child is not infected If PCR or other virological test is not available, use HIV antibody test: x If child becomes sick, test immediately x If child remains well, test at 9-12 months x If child > 12 months has not been tested, recommend HIV antibody test Interpreting the HIV antibody test results in a child <18 months of age Test result HIV antibody test is positive HIV antibody test is negative Not breastfeeding or not breastfed in last 6 weeks HIV exposed and/or HIV infected Manage as if they could be infected. Repeat test at 18 months HIV negative Child is not HIV infected Breastfeeding HIV exposed and/or HIV infected Manage as they could be infected. Repeat test at 18 months or once breastfeeding has been discontinued for more than 6 weeks Child can still be infected by breastfeeding. Repeat test once breastfeeding has been discontinued for more than 6 weeks Integrated management of childhood illness complementary course on HIV/AIDS. WHO; UNICEF, Geneva, 2006; Module 2, p. 17 Effective Perinatal Care (EPC) 10C - 36 Module 11ɋ Infections in Pregnancy, Childbirth and Postpartum Part I Effective Perinatal Care (EPC) 11C - 2 Module 11C 11C - 3 Slide 11ɋ-1-1 Infections in Pregnancy, Childbirth and Postpartum At the end of the module participants will: x Have a basic knowledge on the main infections affecting pregnancy and their possible adverse consequences for the mother and foetus x Know how to manage these infections to prevent complications x Question the current practices of infections prevention in pregnancy and recognize the harm of an inappropriate management x Know the definition of Nosocomial Infection and effective ways of prevention x Understand the importance of hand washing and be able to do it correctly Slide 11ɋ-1-2 Problem Most infections in pregnancy are not worrying, and it is important that those giving care to pregnant women do not impose unnecessary restrictions on the pregnancy, or unnecessarily waste resources. Of course, some infections can be disastrous for mother, baby or both, but they are very much in the minority. In any health care system there is an imperative need not to waste resources, particularly where such resources are limited. Analysis of health care practices in the European region has demonstrated in many countries widespread practices in the field of infections in pregnancy that are either ineffective or, worse still, likely to be harmful. This module will therefore concentrate heavily on interventions that appear at present to be effective, and will attempt to identify practices that are inappropriate. Infections in pregnancy can be subdivided into those which affect pregnancy, and those which do not affect pregnancy. This grouping is important, not least because those in the second category should not be managed in any different way from in the non-pregnant state. There is of course a third category: infections that are influenced by pregnancy. However this category is in effect a sub-category of the above two categories, as will become clear. Not all infections are discussed, and those that are discussed are discussed from the perceptive of the obstetrician/midwife and neonatologist. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen, 2002 Effective Perinatal Care (EPC) 11C - 4 Slide 11ɋ-1-3 Routes and Periods of Contamination of Perinatal Infection The general routes of adult’s infection are: x Sexual intercourse (sexually transmitted infections) x Infected blood (blood-borne infections) x Mosquito’s bite (vector-borne infections) x Infected foods (food-borne infections) x Respiratory (air-borne infections) x Animal faeces (animal-borne infections) x Infected environmental surfaces/staff hands (cross-contamination) Sometime ways of infection can be multiple. Slide 11ɋ-1-4 Infections Affecting Pregnancy There is a list of infections which affect pregnancy. This list is not exhaustive, only the most common infections will be discussed during this module. Slide 11ɋ-1-5 Urinary Tract Infections (UTIs) Escherichia coli remains the single most common organism isolated from bacteriuric women, although this happens proportionally less frequently than for women with acute uncomplicated urinary tract infection. Other Enterobacteriaceae (such as Klebsiella pneumonia) and other organisms (including coagulase-negative staphylococci, Enterococcus species, group B streptococci, and Gardnerella vaginalis) are common as well. Lindsay E. Nicolle et al. Infectious Diseases Society of America Guidelines for the Diagnosis and Treatment of Asymptomatic Module 11C 11C - 5 Bacteriuria in Adults. Infectious Diseases Society of America, February 2005, Issue 40, 643-654. Slide 11ɋ-1-6 Urinary Tract Infections during Pregnancy Urinary tract infections have three clinical aspects: asymptomatic bacteriuria, acute cystitis and pyelonephritis. Asymptomatic bacteriuria is common, with prevalence up to 10% during pregnancy. Acute cystitis is diagnosed by the presence of symptoms, such as dysuria, incontinent and frequent urination in febrile patients with no evidence of systemic illness. The diagnosis of pyelonephritis is made when the presence of bacteriuria is accompanied by systemic symptoms or signs such as fever, nausea, vomiting and flank pain; very often symptoms of lower urinary tract infection. Acute pyelonephritis during pregnancy is a serious systemic disease that can progress to maternal sepsis, preterm labour and preterm delivery. Urinary tract infections, including pyelonephritis, are serious complications that may lead to significant maternal and neonatal morbidity and mortality. Murray W. Enkin et al, A guide to effective care in pregnancy and childbirth, Oxford University Press, 3-rd ed, 2000 Gratacos E, Torres PJ, Vila J, Alonso PL, Cararach V. Screening and treatment of asymptomatic bacteriuria in pregnancy prevent pyelonephritis. J Infect Dis 1994;169:1390-2. Slide 11ɋ-1-7 Diagnosis and Treatment of UTIs during Pregnancy The commonly accepted standard for diagnosis of UTIs is identifying more than 105 colony-forming units per ml of midstream specimen of urine. Urinary tract infections (UTI) are common in pregnancy, but fortunately they can usually be easily and effectively treated with a 5–7 day course (if there are symptoms) of inexpensive antibiotics (local availability will influence the choice: Ampicillin, cephalosporins, or nitrofurantoin are widely used). Women do not need to be admitted to a hospital for straightforward lower UTIs (but see below). Effective Perinatal Care (EPC) 11C - 6 There is a significant increased risk (compared to a non-pregnant woman) of developing an ascending maternal infection (pyelonephritis), which can cause preterm labour, foetal growth retardation or foetal death. Pyelonephritis in pregnancy is a serious infection that could result in permanent renal damage. Hospitalization and administration of IV antibiotics is advised for women with pyelonephritis. Women can be discharged from the hospital within a day or two of the flank pain subsiding, since the infection will then be adequately treated. The challenge therefore lies in trying to ensure that as many women as possible with genuine UTIs are treated, aiming to prevent progression to pyelonephritis, without treating large numbers of women unnecessarily. UTIs are not contagious, and isolation of a woman and/or delivery as though she is “pathological” is illogical and not productive. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care, Copenhagen, 2002 Vazquez JC, Villar J. Treatments for symptomatic urinary tract infections during pregnancy. Cochrane Database of Systematic Reviews 2003, Issue 4. Villar J, Widmer M, Lydon-Rochelle MT, Gülmezoglu AM, Roganti A. Duration of treatment for asymptomatic bacteriuria during pregnancy. Cochrane Database of Systematic Reviews 2000, Issue 2. Slide 11ɋ-1-8 Management of Asymptomatic Bacteriuria during Pregnancy It is unclear why the bacteria don't cause symptoms. It may be that asymptomatic bacteriuria is caused by weaker (less "virulent") microorganisms. Good evidence shows that screening pregnant women for asymptomatic bacteriuria with a urine culture (rather than urinalysis) can lead to a significantly reduction in symptomatic urinary tract infections, low birth weight, and preterm delivery. Antibiotic treatment is effective in reducing the risk of pyelonephritis in pregnancy. An apparent reduction in preterm delivery is consistent with current theories about the role of infection in preterm birth, but this association should be interpreted with caution. F Smaill. Antibiotics for asymptomatic bacteriuria in pregnancy Cochrane Database of Systematic Reviews 2006 Issue 4 U.S. Preventive Services Task Force (USPSTF). Screening for asymptomatic bacteriuria: recommendation statement. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2004 Feb. 5 p. Module 11C 11C - 7 Slide 11ɋ-1-9 Syphilis Treponema pallidum is a gram-negative spirochetes bacterium. Syphilis is an acute and chronic disease characterized clinically by a primary lesion, a secondary eruption involving skin and mucosal membranes, long periods of latency, and late lesions of skin, bone, viscera, the CNS and cardiovascular system. Foetal infection occurs with high frequency in untreated early infections of pregnant women and with lower frequency later in pregnancy. It frequently causes abortion or stillbirth and may cause infant death due to preterm delivery of low birth weight infants or from generalized systemic disease. Murray W. Enkin et al, A guide to effective care in pregnancy and childbirth, 3-rd ed, 2000 James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 Slide 11ɋ-1-10 Diagnosis and Treatment of Syphilis during Pregnancy Syphilis is a classical example of an infection for which an effective treatment and possibility to reduce adverse impact on pregnancy exists: x Reliable and inexpensive diagnostic test x Screening for syphilis is recommended in most countries x Effective, inexpensive and easily available treatment x Diagnostic and treatment reduces the adverse effects of the infection x Women with an allergy to penicillin should be desensitized or referred to a higher level of care. x Partners must be treated. Also women with syphilis have a high risk of carrying other sexually transmitted infections and therefore should be tested for them. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care, Copenhagen, 2002 MMWR August 4, 2006/Vol. 55/No. RR-11 CDC Sexually Transmitted Diseases Treatment Guidelines, 2006. Effective Perinatal Care (EPC) 11C - 8 Murray W. Enkin et al, A guide to effective care in pregnancy and childbirth, 3-rd ed, 2000 The global elimination of congenital syphilis: rationale and strategy for action. Annex 2a Standard for the preventive treatment of mother-to-child transmission of syphilis. World Health Organization, Geneva, 2007 Slide 11ɋ-1-11 Management of a Newborn Born to a Mother with Syphilis Test + Test the newborn with a quantitative non treponemal serologic test (RPR [rapid plasma regain] or VDRL [Venereal Disease Research Laboratory]). For screening newborn infants, serum is preferred over cord blood, which produces more false-positive reactions due to presence of maternal antibodies in it. If the mother tested positive for syphilis and was treated adequately (2.4 million units of penicillin) and the treatment started at least 30 days before birth, NO treatment is necessary. However, some specialists would treat with benzathine penicillin G 50,000 units/kg as a single IM injection, particularly if follow-up was uncertain. (CDC, 2006) If the mother was not treated for syphilis, she was treated inadequately, or her treatment status is unknown or uncertain and the baby has no signs of syphilis: x Give the baby o Benzathine penicillin G 50,000 units/kg/dose IM in a single dose (CDC,2006; WHO, 2007) OR o Procaine benzylpenicillin 50 000 units/kg/dose IM a single dose for 10 days (CDC, 2006). OR o Aqueous crystalline penicillin G, 100,000-150 000 units/kg/dose, administered as 50,000 units/kg/dose IV every 12 hours during the first 7 days of the life, and every 8 hours thereafter for a total of 10 days (CDC, 2006) x Follow up in four weeks to examine the baby for growth and signs of congenital syphilis. MMWR August 4, 2006/Vol. 55/No. RR-11 CDC Sexually Transmitted Diseases Treatment Guidelines, 2006. The global elimination of congenital syphilis: rationale and strategy for action. Annex 2b Standard for the preventive treatment and Module 11C 11C - 9 care of congenital syphilis in the newborn. World Health Organization, Geneva, 2007 Slide 11ɋ-1-12 Congenital Syphilis Clinical evidence of early congenital syphilis is similar to that of secondary syphilis in adults. The rash has a higher probability of being atypical and can be vesicular or bullous instead of the characteristic reddish brown macular rash. Late congenital syphilis mainly manifests with neurologic symptoms. Cardiovascular abnormalities are rare. For early congenital syphilis, aqueous crystalline penicillin G, 50 000 units/kg/dose, given IV or IM every 12 hours during the first 7 days of the life, and every 8 hours thereafter for a total of 10 days OR Procaine penicillin G 50,000 units/kg/dose IM in a single daily dose for 10 days. WHO. Managing Newborn Problems: A guide for doctors, nurses, and midwives. Department of Reproductive Health and Research, World Health Organization, Geneva, 2003 James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 MMWR August 4, 2006/Vol. 55/No. RR-11 CDC Sexually Transmitted Diseases Treatment Guidelines, 2006. The global elimination of congenital syphilis: rationale and strategy for action. Annex 2b Standard for the preventive treatment and care of congenital syphilis in the newborn. World Health Organization, Geneva, 2007 Slide 11ɋ-1-13 Syphilis: Prevention The best approach to preventing syphilis is to avoid exposure. At this first level of prevention, the likelihood of being exposed to syphilis can be reduced by: x Decreasing the number of sex partners; x Using condoms correctly and consistently. Syphilis prevention involves its prompt recognition and effective treatment when it Effective Perinatal Care (EPC) 11C - 10 does occur. This not only reduces the probability of complications for the individual but also prevents new infections including vertical transmission. The sooner syphilis is cured, the less chance it will be transmitted. WHO. Sexually Transmitted and Other Reproductive Tract Infections. A guide to essential practice. Geneva, 2003 Slide 11ɋ-1-14 Gonorrhoea Gonorrhoea is a sexually transmitted disease. Gonorrhoea in pregnancy is associated with several adverse outcomes, including chorioamnionitis, preterm rupture of membranes, and preterm delivery. Perinatal transmission to infants can cause severe conjunctivitis resulting in blindness. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen. 2002 James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 Slide 11ɋ-1-15 Diagnosis and Treatment of Gonorrhoea during Pregnancy In a region with a high prevalence of gonorrhoea, it can be argued that screening for gonorrhoea might be effective. The Centre for Disease Control and Prevention (CDC) recommends a culture specimen as a test for screening. Clinicians should consider all positive screening tests presumptive evidence of infection and consider additional testing when screening in a low-prevalence populations Thus, routine screening with bacterioscopy is not effective and not recommended. Where the prevalence of penicillin-resistant gonorrhoea is high, certain third-generation cephalosporin are recommended for treatment. Because simultaneous infection with Chlamydia is common, anti-chlamydial treatment is also given if gonorrhoea is diagnosed. Women do not need to be admitted to the hospital for treatment, but it is important to confirm by further bacteriological swabs that the infection has been eradicated. Once treated a woman does not have to be isolated from Module 11C 11C - 11 other women, nor does she pose a risk to her baby – assuming that she does not become re-infected by her sexual partner. For this reason it is most important that her partner is tested and treated where appropriate. Screening for Gonorrhea: Recommendation Statement: U.S. Preventive Services Task Force. Fam Med. 2005;3(3):263-267 WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen., 2002 Sexually transmitted diseases treatment guidelines 2002. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002;51 (RR-6):1-78. Slide 11ɋ-1-16 Management of a Newborn Born to the Mother with Gonorrhoea Neonatal conjunctivitis (Gonorrheal ophthalmia neonatorum) – acute redness and swelling of the conjunctiva of one or both eyes, with mucopurulent or purulent discharge. Corneal ulcer, perforation and blindness may occur if specific treatment is not given promptly. If eyes draining pus (conjunctivitis): x Take a specimen of pus, if it can be easily obtained, using a sterile cotton swab (take care to avoid direct contact with the baby eyes). x Send a sample of the pus to the laboratory for Gram stain or culture and sensitivity. x Give Ceftriaxone IM 50 mg/kg (0.5 ml/kg) in a single dose. x Clean the eyelids using sterile normal saline or clean (boiled and cooled) water and a clean swab, cleaning from the inside edge of the eye to the outside edge (have the mother do this whenever possible). Repeat 4 times daily until the eye problems have cleared. x Have the mother wash the baby’s face once daily (or more often, if necessary) using clean water, and dry with a clean cloth. James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 WHO. Managing Newborn Problems: A guide for doctors, nurses, and midwives. Department of Reproductive Health and Research, World Health Organization, Geneva, 2003 Effective Perinatal Care (EPC) 11C - 12 Slide 11ɋ-1-17 Gonorrhoea: Prevention The best approach to preventing gonorrhea is to avoid exposure. At this first level of prevention, the likelihood of being exposed to gonorrhea can be reduced by: x Decreasing the number of sex partners; x Using condoms correctly and consistently. Gonorrhea prevention involves its prompt recognition and effective treatment when it does occur. This not only reduces the probability of complications for the individual but also prevents new infections including vertical transmission. The sooner gonorrhea is cured, the less chance it will be transmitted. WHO. Sexually Transmitted and Other Reproductive Tract Infections. A guide to essential practice. Geneva, 2003 The ideal method of preventing neonatal ophthalmia is detection and early treatment of maternal gonorrhoea. Cohort studies of tetracycline, erythromycin and penicillin suggest that these agents are both less irritating and more effective prophylactics than silver nitrate, and they are also effective against chlamydia infection. Murray W. Enkin et al, A guide to effective care in pregnancy and childbirth, 3-rd ed, 2000 WHO recommendations on prevention of gonococci ophthalmia neonatorum: x Apply an antimicrobial agent in the eyes of the newborn within 1 hour of birth. x Antimicrobial agent can be used: either 1% silver nitrate drops or 2.5% povidone iodine drops or 1% tetracycline ointment. x Do not wash away the eye antimicrobial. WHO, Pregnancy, Childbirth, Postpartum and Newborn Care: A guide for essential practice. Geneva, 2006 Module 11C 11C - 13 Slide 11ɋ-1-18 Chlamydiosis Chlamydiosis is a sexually transmitted infection frequently asymptomatic. Mucopurulent cervicitis is the most frequent clinical sign. Chlamydia infection during pregnancy is associated with higher rates of preterm birth (OR 1.6, 90% CI 1.01 to 2.5) and intrauterine growth retardation (OR 2.5, 90% CI 1.32 to 4.18). Left untreated, it has also been associated with increased low birth weight and neonatal mortality. Maternal to infant transmission can lead to neonatal conjunctivitis and pneumonia in 30– 40% of cases. Chlamydia may coexist with other genital infections and may facilitate transmission of HIV infection. Scottish Intercollegiate Guidelines Network. Management of genital Chlamydia trachomatis infection. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2000 Mar. 26 p. (SIGN publication; no. 42). Antenatal care: routine care for the healthy pregnant woman. Clinical Guideline. National Collaborating Centre for Women’s and Children’s Health. RCOG Press, October 2003 Slide 11ɋ-1-19 Chlamydiosis: Diagnosis and Treatment in Pregnancy Currently, there is no simple inexpensive laboratory test to diagnose C. trachomatis. Serology is not useful in the diagnosis of acute chlamydial infection. Routine screening for asymptomatic chlamydia during pregnancy should not be offered because there is insufficient evidence on its clinical and cost effectiveness. Uncomplicated genital chlamydia infection in pregnancy should be treated with: x Erythromycin 500 mg four times/day for 7 days, or x Amoxicillin 500 mg three times/day for 7 days x Another option includes Azithromycin or Clindamycin. Effective Perinatal Care (EPC) 11C - 14 In a review of randomized control trials, the number of women with positive cultures for chlamydia was reduced by 90% when treated with antibiotics compared to placebo (OR 0.06, 95% CI 0.03 to 0.12). Scottish Intercollegiate Guidelines Network. Management of genital Chlamydia trachomatis infection. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2000 Mar. 26 p. (SIGN publication; no. 42). Antenatal care: routine care for the healthy pregnant woman. Clinical Guideline. National Collaborating Centre for Women’s and Children’s Health. RCOG Press, October 2003 James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 MMWR August 4, 2006/Vol. 55/No. RR-11 CDC Sexually Transmitted Diseases Treatment Guidelines, 2006. Slide 11ɋ-1-20 Management of a Newborn Born to the Mother with Chlamydiosis Chlamydia infection in newborn is treated with Erythromycin for 14 days. In the case of conjunctivitis: x Take a specimen of pus, if it can be easily obtained, using a sterile cotton swab (take care to avoid direct contact with the baby eyes). x Send a sample of the pus to the laboratory for Gram stain or culture and sensitivity. x Give Erythromycin by mouth for 14 days. x Clean the eyelids using sterile normal saline or clean (boiled and cooled) water and a clean swab, cleaning from the inside edge of the eye to the outside edge (have the mother do this whenever possible). Repeat 4 times daily until the eye problems have cleared. x After cleaning the eye, apply 1% tetracycline ointment in the affected eye(s) 4 times daily until the eyes are no longer red, swollen, sticky, or draining pus. WHO. Managing Newborn Problems: A guide for doctors, nurses, and midwives. Department of Reproductive Health and Research, World Health Organization, Geneva, 2003 Module 11C 11C - 15 Slide 11ɋ-1-21 Chlamydiosis: Prevention The best approach to preventing chlamydiosis is to avoid exposure. At this first level of prevention, the likelihood of being exposed to chlamydiosis can be reduced by: x Decreasing the number of sex partners; x Using condoms correctly and consistently. Chlamydiosis prevention involves its prompt recognition and effective treatment when it do occur. The sooner chlamydiosis is cured, the less chance it will be transmitted. WHO. Sexually Transmitted and Other Reproductive Tract Infections. A guide to essential practice. Geneva, 2003 Prevention of chlamydia conjunctivitis: x Universal prophylactic treatment within 1 hour after birth with Erythromycin (0.5%) or Tetracycline (1%) ointment in both eyes . WHO. Managing Newborn Problems: A guide for doctors, nurses, and midwives. Department of Reproductive Health and Research, World Health Organization, Geneva, 2003 Slide 11ɋ-1-22 Bacterial Vaginosis Bacterial vaginosis during pregnancy has been associated with poor perinatal outcome and, in particular, preterm birth. The infection is a recognised cause of PROM, chorioamnionitis and postpartum endometritis. M Riduan Joesoef and George Schmid. Bacterial Vaginosis. Clin Evid 2005;13:1–3. McDonald HM, Brocklehurst P, Gordon A. Antibiotics for treating bacterial vaginosis in pregnancy. Cochrane Database of Systematic Reviews 2007, Issue 1. Effective Perinatal Care (EPC) 11C - 16 Slide 11ɋ-1-23 Bacterial Vaginosis (BV): Diagnosis and Treatment in Pregnancy Antibiotic treatment can eradicate bacterial vaginosis in pregnancy. Treating all pregnant women with asymptomatic bacterial vaginosis will prevent preterm birth and its consequences. However, there is some suggestion that treatment before 20 weeks' gestation may reduce the risk of preterm birth. McDonald HM, Brocklehurst P, Gordon A. Antibiotics for treating bacterial vaginosis in pregnancy. Cochrane Database of Systematic Reviews 2007, Issue 1. Bacterial vaginosis (BV) increases the risk of preterm birth and preterm prelabour rupture of the membranes. Antibiotic treatment decreased preterm prelabour rupture of membranes and low birth weight significantly but only in the subgroup of women who had a previous preterm birth. The effectiveness of treatment of BV is high and there seem to be few adverse effects from the drug. Since the above benefits are unlikely to improve neonatal well-being, in developing countries there may be no justification for implementing routine screening and treatment of bacterial vaginosis. Jadsada Thinkhamrop. Interventions for treating bacterial vaginosis in pregnancy: RHL commentary (last revised: 13 March 2006). The WHO Reproductive Health Library, No 9, Update Software Ltd, Oxford, 2006 Local therapy leads to elimination of infection. x Clindamycin locally during 7 days, OR x Metronidazole gel locally during 7 days. Marie-Louise Newell, James McIntyre. Congenital and perinatal infection : Prevention, diagnosis and treatment. Cambridge University Press, 2000 Module 11C 11C - 17 Slide 11ɋ-1-24 Management of a Newborn Born to a Mother with Bacterial Vaginosis There is no significant correlation between BV and neonatal infection. In absence of clinical signs of infection in newborn the last do not need any specific evaluation or treatment. Marie-Louise Newell, James McIntyre. Congenital and perinatal infection: Prevention, diagnosis and treatment. Cambridge University Press, 2000 Slide 11ɋ-1-25 Group B Streptococcus (GBS) Group B streptococcus is a bacterium that normally lives in the intestine, vagina, or rectal areas. GBS colonization is not a sexually transmitted disease. (CDC, 2008). Group B Streptococci can be found in the genital tract of 10-30% of pregnant women. Group B streptococcus is an important (major) cause of neonatal sepsis and mortality: x 0.5-3 cases in 1000 newborns x Mortality without treatment is 50% x Complications occur in 50% of survivors WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen, 2002 Centers for Disease Control and Prevention. Group B strep prevention; general public, frequently asked questions, CDC, 2008. Effective Perinatal Care (EPC) 11C - 18 Slide 11ɋ-1-26 Management Approaches to GBS during Pregnancy Today, there are still considerable disagreements world-wide on the proper approach of this infection. Being a very important cause of neonatal sepsis and death, countries use different preventive strategies and it is no agreement on these strategies. They differ in costs and effectiveness. 1. The first approach is universal screening in late pregnancy and antibiotic treatment in labour of all women tested positive. This approach prevents 65% - 80% of all cases of neonatal sepsis with group B streptococcus (USA). Disadvantages: almost 30% of all pregnant women should be treated with antibiotics (risk of allergic reactions, anaphylaxis, antibiotic resistance concerns).;. To prevent one neonatal death 24,000 pregnant women should be tested and 7,000 treated with antibiotics. Expensive methodology 2. The second approach is – antibiotic treatment in labour for women with high risk factors: x Preterm delivery x Fever in labour x Prolonged rupture of membranes >18 hours x Previous baby with Group B streptococcus disease x Group B streptococcus bacteriuria in the current pregnancy. With this approach, to prevent one neonatal death it is necessary to treat 5,580 women in labour with high risk factors, to prevent one case of disease – 625; 65% of all cases will be prevented. Advantages: less expensive – no screening and antibiotics are used less often (in 15% of women with risk factors). Disadvantages: a lower proportion of neonatal Group B streptococcal infection are prevented, many women are treated with antibiotics. Prevention of early onset neonatal group B streptococcal disease. Royal College of Obstetricians Gynaecologists. Guideline N 36, November 2003 3. A third suggested approach is to screen all women and to treat with antibiotic during labour the GBS carriers who also have clinical risk factors. This policy has been suggested by the Canadian Task Force on Preventative Health Care. In this approach 3.4% of women received intrapartum antibiotic leading to decrease the incidence of early sepsis GBS by 51%. Advantages: antibiotics are used in a smaller proportion of pregnant women Module 11C 11C - 19 Disadvantages: high cost of screening, less effective approach. Prevention of group B streptococcal infection in newborns: recommendation statement from the Canadian Task Force on Preventive Health Care. CMAJ 2002 Apr 2;166(7):928-30. Slide 11ɋ-1-27 Intrapartum GBS Treatment There are different approaches to the intrapartum treatment of GBS If none known allergy to penicillin: x The recommended treatment is IV Penicillin G : 5 million units given first then 2.5 million units IV every four hours until delivery. x Alternative treatment: Ampicillin: 2 g given in an IV load; then 1 g IV every four hours until delivery. In case to Penicillin allergy: x Clindamycin (Cleocin): 900 mg IV every eight hours until delivery, or x Erythromycin: 500 mg IV every six hours until delivery WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen, 2002 Prevention of early onset neonatal group B streptococcal disease. Royal College of Obstetric and Gynaecology. Guideline No. 36, November 2003 Centers for Disease Control and Prevention. Prevention of perinatal group B streptococcal disease: a public health perspective. MMWR Morb Mortal Weekly Rep 1996;45(RR-7):1-24 Slide 11ɋ-1-28 Antibiotic Administration and Group B Streptococcal Infection The results of the trials show that the minimal exposure to antibiotic should exceed 4 hours, that is, to reduce colonization level; over 4 hours must pass from antibiotic administration until the birth of the baby. In this case, the rate of neonatal colonization with Group B Streptococcus reduces to <1%. Therefore, the exact time of intrapartum antibiotic administration must be carefully recorded. Effective Perinatal Care (EPC) 11C - 20 M de Cueto, MJ Sanchez, A Sampedro, JA Miranda, AJ Herruzo, and M Rosa-Fraile. Timing of intrapartum ampicillin and prevention of vertical transmission of group B streptococcus. Obstetrics & Gynecology 1998;91:112-114. Slide 11ɋ-1-29 Management of a Newborn Born to a Mother with GBS (1) This algorithm presents the CDC- recommendations of newborn care, depending on intranatal antibiotic prophylaxis, gestation term and presence of clinical signs in the baby. Perinatal Group B Streptococcal Disease Prevention, CDC Aug 16, 2002 Slide 11ɋ-1-30 Management of a Newborn Born to a Mother with GBS (2) GBS colonization in woman should not affect breastfeeding in any way, as well as should not be an indication for mother and baby separation. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care, Copenhagen, 2002 Slide 11ɋ-1-31 Listeriosis Listeriosis, a serious infection caused by eating food contaminated with Listeria monocytogenes, has recently been recognized as an important public health problem. Pregnant women are about 20 times more likely than other healthy adults to get listeriosis. About one-third of listeriosis cases happen during pregnancy. Module 11C 11C - 21 Babies can be born with listeriosis if their mothers eat contaminated food during pregnancy. Maternal listeriosis in the second or third trimester results in a mortality of 40-50% for the foetus. In later pregnancy foetal septicaemia may result in damage to multiple organs and stillbirth or neonatal death. Perinatal listeria within 7 days of birth is often associated with prematurity and fulminant disease. Late onset disease (7 days to six weeks) often presenting with meningitis Listeriosis. National Center for Infectious Diseases/ Centers for Disease Control and Prevention (CDC). October 12, 2005 Slide 11ɋ-1-32 Diagnosis and Treatment of Listeriosis during Pregnancy Infection in the mother is usually a retrospective diagnosis because the infection presents a mild flu-like illness. There is no routine screening test for susceptibility to listeriosis during pregnancy. During pregnancy, a blood test is the most reliable way to find out if presented symptoms are due to listeriosis. Recommended regimens of treatment: x Mild infections: Amoxicillin/Ampicillin 2-3 g/day per os for 14 days x Serious infections: Amoxicillin/Ampicillin 4-5g/day IV and Gentamicin for 14 days x If allergy to penicillin, use Cotrimoxazole for 14 days Listeriosis. National Center for Infectious Diseases/ Centers for Disease Control and Prevention (CDC). October 12, 2005 Australasian Society for Infectious Diseases. Management of Perinatal Infections. Guideline for Listeria in pregnancy, 2002 Slide 11ɋ-1-33 Management of a Newborn Born to a Mother with Listeriosis Babies with listeriosis should receive the same antibiotics used to treat their mothers, although a combination of antibiotics is often used until physicians are certain of the diagnosis. Diagnosis is confirmed by isolation of Listeria from CSF, blood, amniotic fluid, placenta, and meconium. Effective Perinatal Care (EPC) 11C - 22 Management recommended algorithm: x Take the material for diagnosis just after delivery to confirm the diagnosis. x Start the treatment with antibiotics with (.recommended regimens): o Amoxicillin/ampicillin (50 mg/kg every 12 hours), AND o Gentamicin (2.5 mg/kg every 12 hours) o Consider Cotrimoxazole if no response to standard therapy After receiving the laboratory results: x Well newborn o Cease antibiotics after 48 hours x Culture positive or unwell newborn o If cerebrospinal fluid is positive continue amoxicillin / ampicillin and gentamicin for >21 days o If cerebrospinal fluid is negative continue amoxicillin / ampicillin and gentamicin for only >14 days Smith, J, Foodborne Infections during Pregnancy. Journal of Food Protection, 1999, Vol. 62, No. 7, 818-829. Australasian Society for Infectious Diseases. Management of Perinatal Infections. Guideline for Listeria in pregnancy, 2002 Slide 11ɋ-1-34 Listeriosis: Prevention General recommendations: x Keep uncooked meats separate from vegetables and from cooked foods and ready-to-eat foods. x Wash hands, knives, and cutting boards after handling uncooked foods. x Consume perishable and ready-to- eat foods as soon as possible. When infection occurs during pregnancy, antibiotics given promptly to the pregnant woman can often prevent infection of the foetus or newborn. Listeriosis. National Center for Infectious Diseases/ Centers for Disease Control and Prevention (CDC). October 12, 2005 Module 11C 11C - 23 Slide 11ɋ-1-35 Tuberculosis (TB) Tuberculosis is a mycobacterial disease that is a major cause and death in many parts of the world. The recent increase in numbers of cases of tuberculosis in the European region indicates that this is a significant public health issue in the region. Because TB usually is transmitted by air, acquisition of tubercle bacilli by newborns generally occurs after delivery, Infection can occur before birth as a result of haematogenous dissemination which seeds the placenta; as a result of infected amniotic fluid in utero; or at the time of delivery as a result of foetal aspiration of tubercle bacilli in women with tuberculosis endometritis. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care, Copenhagen, 2002 James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 Slide 11ɋ-1-36 Diagnosis and Treatment of Tuberculosis during Pregnancy All pregnant women who are at high risk of TB at the first antenatal visit , screening should be done by Mantoux skin test with purified protein derivative (PPD) . High risk factors for TB include: x HIV infection x Close contact with individuals known or suspected to have TB x Medical risk factors known to increase risk of disease (e.g., lymphoma, diabetes mellitus, chronic renal failure, HIV/AIDS immunosupression) x Country with a high prevalence of TB x Medically underserved status x Low socioeconomic status x Alcohol addiction x Intravenous drug use x Residence in a long-term care facility (e.g., prisons, mental institutions, nursing homes ) Effective Perinatal Care (EPC) 11C - 24 x Healthcare professionals working in facilities where the risk of exposure to tubercle bacilli is increased A positive skin test does not precise the date of seroconversion. Pregnant women with a positive Mantoux test need to have chest X-rays. If chest X-rays are normal, some experts prefer to delay treatment until after delivery because pregnancy itself does not increase risk for progression of disease and because of an increased risk of hepatoxicity during pregnancy and immediately postpartum. Other experts recommend treatment with careful monitoring for hepatitis. Treatment should be decided by trained specialists. All pregnant women receiving Isoniazid also should take Pyridoxine. American Academy of Pediatrics, The American College of Obstetricians and Gynecologists. Guidelines for PERINATAL CARE. 5th Edition, October 2002 Slide 11ɋ-1-37 Management of a Newborn Born to a Mother with TB (1) Management of a newborn whose mother is suspected of having TB is based on several considerations but whenever possible, separation of the mother and the neonate should be minimized. Mother with Mantoux test +, but asymptomatic and having a negative X- ray: - No separation of the mother and the neonate. - The mother usually is a candidate for treatment of latent TB infection. - The newborn needs no special evaluation or therapy. Mother with Mantoux test + and having abnormal X-rays - The mother and the neonate should be separated until the mother has been evaluated and, if active TB disease is found, until she is receiving antituberculosis therapy. o If the history, physical examinations, sputum smear, and X-ray indicate no evidence of active disease, the neonate can be assumed to be at low risk of TB infection. The radiographic abnormality in this circumstance is probably because of another cause or because of a quiescent focus of TB. In the latter case, the mother may develop contagious, active TB, if untreated, and should receive appropriate therapy, if not previously treated. She and her neonate should receive follow up care. Module 11C 11C - 25 o If the mother has clinical or radiographic evidence of active, possibly contagious TB, the neonate should be evaluated for congenital TB and for HIV infection. The mother and the neonate should be separated until both are receiving appropriate therapy and the mother is deemed to be non- contiguous. American Academy of Pediatrics, The American College of Obstetricians and Gynecologists. Guidelines for PERINATAL CARE. 5th Edition, October 2002 Slide 11ɋ-1-38 Management of a Newborn Born to a Mother with TB (2) If the mother has active TB and was treated for less than two months before birth or was diagnosed with TB after birth: x Do not give the tuberculosis vaccine (BCG) at birth. x Give prophylactic Isoniazid 5 mg/kg body weight by mouth once daily. x At the age of six weeks, re-evaluate the baby, noting weight gain and taking an X-ray of the chest, if possible: o If there are any findings suggestive of active disease, start full anti-TB treatment. o If the baby is doing well and tests are negative, continue prophylactic Isoniazid to complete six months of treatment. x Delay BCG vaccine until two weeks after treatment is completed. If BCG was already done, repeat it 2 weeks after the end of the Isoniazid treatment. x Reassure the mother that it is safe for her to breastfeed her baby. WHO. Managing Newborn Problems: A guide for doctors, nurses, and midwives. Department of Reproductive Health and Research, World Health Organization, Geneva, 2003 Slide 11ɋ-1-39 Tuberculosis: Prevention General recommendations on preventative measures: x BCG vaccination for all newborns x To avoid contacts with potentially infected people. TB is generally not spread by casual contact, but typically requires relatively prolonged contact in shared airspace. Therefore it is worth reiterating that anyone with active TB disease, Effective Perinatal Care (EPC) 11C - 26 regardless of whether it is drug-resistant, should avoid situations that place them in prolonged contact with others, including flying on commercial aircraft. Protecting the Public's Health against Tuberculosis: Moving Forward. Centers for Disease Control and Prevention. July 26, 2005 Slide 11ɋ-1-40 Hepatitis B Vertical transmission can occur: x In 10% - if maternal infection occurs in the 1st trimester. x In 80 - 90% - if it occurs in the 3rd trimester. x In 10-20% - if a woman is seropositive for HBsAg. x In 90% - if a woman is seropositive for both HBsAg and HBeAg. Hepatitis B infection it is not teratogenic. Majority of women with a hepatitis B infection acquired it before pregnancy. Only if the mother has contracted the infection in pregnancy, the foetus can be infected in uteri, which is rare. ACOG educational bulletin. Viral hepatitis in pregnancy. Number 248, July 1998 . American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1998 ;63:195-202. Slide 11ɋ-1-41 Diagnosis and Treatment of Hepatitis B during Pregnancy There is no treatment for acute maternal hepatitis B except supportive measures,. Identification of the chronic carrier state in pregnant women is very important because babies born to such mothers are at significant risk of becoming infected at birth. Congenital infection results in a chronic carrier state more frequently than being infected as an adult, therefore all babies from these mothers should receive immunoglobulin of hepatitis B and a vaccine. Association for Genitourinary Medicine (AGUM), Medical Society for the Study of Venereal Disease (MSSVD). 2002 national guideline on the management of the viral hepatitis A, B, and C. London, 2002 Module 11C 11C - 27 Gwendolyn L Gilbert. The Infections in pregnant women. Medical Journal of Australia 4 March 2002 176 5: 229-236 ACOG educational bulletin. Viral hepatitis in pregnancy. Number 248, July 1998 . American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1998 ;63:195-202. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen, 2002 Slide 11ɋ-1-42 Management of a Newborn Born to a Mother with Hepatitis B Hepatitis B vaccine, hepatitis B immunoglobulin, or vaccine + immunoglobulin prevent hepatitis B occurrence in newborn infants of mothers positive for hepatitis B surface antigen. Chuanfang Lee et al., Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis BMJ 2006; 332:328-336 Slide 11ɋ-1-43 Hepatitis B: Prevention General recommendations on prevention of Hepatitis B: x Avoid unprotected sex x Routine infant immunization with Hepatitis B vaccine should be the primary strategy to prevent HBV infection. Pregnancy is not a contraindication for receiving hepatitis B vaccine. x Avoid sharing drug needles x Avoid unsanitary tattoo, body piercing methods x Avoid needle stick injury ` x Avoid sharing grooming utensils for manicure /pedicure x Special childbirth handling if mother is HepB positive x Breastfeeding is not contraindicated after vaccination WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen, 2002 Effective Perinatal Care (EPC) 11C - 28 James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 Slide 11ɋ-1-44 Genital Herpes Neonatal herpes is a severe systemic viral infection with a high morbidity and mortality, which is most commonly acquired at or near the time of delivery. If maternal infection is primary, the risk to the infant to be infected is 33-50%. If it is known recurrent lesion in the woman, the risk to the infant to be infected is 1-3%. Herpes infections in pregnant women and neonates. A CME publication of the American Herpes Foundation. The Herpes Monitor, Vol. 4, No. 1, March 2004 Management of genital herpes in pregnancy. Royal College of Obstetricians and Gynaecologists. Clinical Guideline No. 30, March 2002 Slide 11ɋ-1-45 Diagnosis of Genital Herpes during Pregnancy Type-specific HSV serology is thought to be a more accurate way of detecting women susceptible to HSV infection in pregnancy. As the greatest risk of neonatal herpes occurs when women acquire genital herpes at or near the time of delivery, it has been proposed that serological testing should be undertaken in the latter half of pregnancy in order to identify susceptible women. Since the severe consequences of neonatal herpes infection are well established, obstetricians need to be aware of interventions that may reduce the risk of perinatal transmission. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen, 2002 Eva Jungmann. Genital herpes. Clin Evid, 2004;12:1–3. Module 11C 11C - 29 Management of genital herpes in pregnancy. Royal College of Obstetricians and Gynaecologists. Clinical Guideline No. 30, March 2002 Slide 11ɋ-1-46 Management of a First Episode of Genital Herpes during Pregnancy Treatment with Aciclovir should be considered for all women who develop a first episode of genital herpes in pregnancy. Aciclovir is well tolerated in late pregnancy and there is no clinical or laboratory evidence of maternal or foetal toxicity. Caesarean section is not indicated for women who develop first episode genital herpes lesions during the first or second trimesters. Management of genital herpes in pregnancy. Royal College of Obstetricians and Gynaecologists. Clinical Guideline No. 30, March 2002 Slide 11ɋ-1-47 Management of a Recurrent Genital Herpes during Pregnancy If during pregnancy the recurrent episode of genital herpes occurred at any other time then the onset of labour it is not an indication for delivery by caesarean section. Recurrent genital herpes infection is associated with a much smaller risk of neonatal herpes. Where vaginal delivery is associated with recurrent genital HSV lesions, one study reported a perinatal HSV transmission rate of 3% (1/34) and another study reported a rate of 0% (0/34; 95% CI 0–8%). In the aforementioned study of 7046 pregnant women susceptible to HSV infection, none of the babies diagnosed with HSV was born to a woman who had acquired HSV-2 antibodies prior to pregnancy. Moreover, in the Netherlands caesarean sections have not been routinely performed for this indication since 1987 and there has been no increase in the reported incidence of neonatal herpes. Management of genital herpes in pregnancy. Royal College of Obstetricians and Gynaecologists. Clinical Guideline No. 30, March 2002 Effective Perinatal Care (EPC) 11C - 30 American College of Obstetricians and Gynaecologists. Management of herpes in pregnancy. (ACOG practice bulletin, No. 8), 2004 Slide 11ɋ-1-48 Management of a Newborn Born to a Mother with Genital Herpes If it is known recurrent lesion and the infants are symptomatic: x Educate the parents regarding the signs and symptoms of early herpes infection. x Consider surface screen cultures of the infant at 24-48 hours of age. x Treat if symptoms develop or if the culture is positive. If maternal infection is primary: x Most clinicians recommend empiric acyclovir at birth after cultures have been done. Some support no treatment initially if the infant is asymptomatic, and obtain cultures at 24-48 hours of age. The first-line drug is Acyclovir with current recommendations for high-dose therapy of 60 mg/kg/day for 21 days. Tricia Lacy Gomella et al. Neonatology. Management, Procedures, On-Call Problems, Diseases, and Drugs. 5th Edition, Medical Publishing Division, 2004. Slide 11ɋ-1-49 Genital Herpes: Prevention The best approach to preventing genital herpes is to avoid exposure. At this first level of prevention, the likelihood of being exposed to genital herpes can be reduced by: x Decreasing the number of sex partners; x Using condoms correctly and consistently. Genital herpes prevention involves its prompt recognition and effective treatment when it does occur. This not only reduces the probability of complications for the individual but also prevents new infections including transmission to the baby. WHO. Sexually Transmitted and Other Reproductive Tract Infections. A guide to essential practice. Geneva, 2003 Module 11C 11C - 31 Slide 11ɋ-1- 50 Cytomegalovirus (CMV) Infection (1) The risk of CMV-related complications in women who have been infected at least 6 months prior to conception is very low and does not exceed 1%. Cytomegalovirus (CMV). National Centers for Infectious Diseases Control (CDC), Division of Viral and Rickettsial Diseases, 2006 Stagno, S., and R. J. Whitley. Herpes virus infection of pregnancy. N. Engl. J. Med. 1985. 313:1270-1274 Slide 11ɋ-1-51 Cytomegalovirus (CMV) Infection (2) The reported transmission rates to the foetus are between 24 and 75%, with an average transmission rate of about 40%. Of the approximately 40% of foetuses that become infected, 10% of neonates show symptoms of congenital CMV infections after primary maternal infection at birth. Cytomegalovirus (CMV). National Centers for Infectious Diseases Control (CDC), Division of Viral and Rickettsial Diseases, 2006 Tricia Lacy Gomella et al. Neonatology. Management, Procedures, On-Call Problems, Diseases, and Drugs. 5th Edition, Medical Publishing Division, 2004 Organization of teratology information services (OTIS), Cytomegalovirus and Pregnancy, December 2001 Slide 11ɋ-1-52 Diagnosis and Treatment of CMV during Pregnancy Most women have no symptoms, although some have a disease that is similar to mononucleosis. At present, antenatal screening for CMV is thought to be inappropriate, as it is not currently possible to accurately determine which pregnancies are likely to result in the birth of an infected infant, or which infected infants will have Effective Perinatal Care (EPC) 11C - 32 serious sequelae. In addition, currently there is neither available vaccine nor prophylactic therapy for the prevention of transmission and no way to determine whether intrauterine transmission has occurred. The available evidence does not support routine CMV screening in pregnant women and it should not be offered. It is essential to remember that nowadays there is no proven effective way to treat an established infection. (Ganciclovir is mutagenic, teratogenic, and carcinogenic). Antenatal care: routine care for the healthy pregnant woman National Collaborating Centre for Women’s and Children’s Health Commissioned by the National Institute for Clinical Excellence RCOG October 2003 National Center for Infectious Diseases, Division of Viral and Rickettsial Diseases, 2006 Maria Grazia Revello and Giuseppe Gerna. Diagnosis and Management of Human Cytomegalovirus Infection in the Mother, Fetus, and Newborn Infant. Clinical Microbiology Reviews, October 2002, p. 680-715, Vol. 15, No. 4 Slide 11ɋ-1-53 Management of a Newborn Born a Mother with CMV Infection (1) CMV remains the most important cause of congenital viral infection. Infections in newborns have two aspects: - 10-15% of infected foetuses will develop generalized infection after birth .Symptoms may range from moderate enlargement of the liver and spleen (with jaundice) to severe generalized disease. 80% to 90% of survivors will have complications within the first few years of life. - 90% of all infected foetuses will be asymptomatic infection at birth. 5% - 10% of them will subsequently have varying degrees of hearing and mental or coordination problems. The “gold standard” for CMV diagnosis is urine and saliva culture. Most urine specimens from infants with congenital CMV are positive within 48-72nhours. Given that saliva can be collected with less difficultly and expense, it may eventually replace the current use of urine screening. No antiviral agent is yet approved for treatment of congenital CMV. The decision to breastfeed a very low birth weight infant needs to consider the potential benefits of human milk versus the risk of CMV transmission. The benefits of breastfeeding a preterm infant versus the risk of transferring CMV in the human milk remain controversial. “…the benefits of breastfeeding greatly outweigh the Module 11C 11C - 33 minimal risk, if any, of infections transmitted to term infants. Caution is warranted, however, in low-birth-weight premature infants, who are at increased risk of CMV disease. Interventions to screen breast milk, or attempt to render breast milk non- infectious through treatments such as freezing, may be warranted in high-risk premature infants” “…a more recent study that used more sensitive tests for quantitative detection of CMV in breastmilk has shown that late viral RNA and viral infectivity are preserved even after freezing at –20 C for up to 10 days. Pasteurization removes CMV infectivity and should be carried out with donated milk. For a mother known to be infected with CMV, freeze storage of her own milk does not seem to be a perfect solution, but the rate of CMV transmission is likely to be lowered; the observed infections were asymptomatic. Tricia Lacy Gomella et al. Neonatology. Management, Procedures, On-Call Problems, Diseases, and Drugs. 5th Edition, Medical Publishing Division, 2004 American Academy of Paediatrics, The American College of Obstetricians and Gynaecologists. Guidelines for PERINATAL CARE. 5th Edition, October 2002 Cytomegalovirus (CMV). National Centers for Infectious Diseases Control (CDC), Division of Viral and Rickettsial Diseases, 2006 American Academy of Paediatrics. Breastfeeding and the Use of Human Milk. Pediatrics; 115;496-506, 2005. Schleiss, MR. Role of breast milk in acquisition of cytomegalovirus infection: recent advances. Current Opinions Pediatrics, Feb; 18(1):48-52, 2005. Edmond, K and Rajiv, B. Optimal feeding of low-birth-weight infants: technical review. World Health Organization, 2006 Slide 11ɋ-1-54 Management of a Newborn Born a Mother with CMV Infection (2) Affected infants may excrete the virus for months to years and are often a concern to personnel caring for them. These newborns need to be isolated from they other one and room in with their mothers. Cytomegalovirus (CMV). National Centers for Infectious Diseases Control (CDC), Division of Viral and Rickettsial Diseases, 2006 Effective Perinatal Care (EPC) 11C - 34 Slide 11ɋ-1-55 CMV Infection: Prevention Efforts are focused primarily on the development of a safe vaccine. Standard precautions, especially good hand washing after diaper changes, are particularly important for pregnant personnel. Tricia Lacy Gomella et al. Neonatology. Management, Procedures, On-Call Problems, Diseases, and Drugs. 5th Edition, Medical Publishing Division, 2004 Slide 11ɋ-1-56 Rubella (German Measles) Maternal infection occurring in early pregnancy is teratogenic. The risk for the foetus is maximal if the primary maternal infection occurs before 16 weeks of gestation. Termination should be offered when maternal infection is diagnosed during the first 16 weeks of pregnancy. Routine use of immunoglobulin for post-exposure prophylaxis is not recommended, although it may have a role where maternal rubella occurs and termination of pregnancy is not an option. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth, Oxford university press, Third edition, 2000 Slide 11ɋ-1-57 Diagnosis and Treatment of Rubella during Pregnancy Prenatal screening should be carried out on all pregnant women without documented immunity at the first appointment ideally prior to 12 week of gestation. The diagnosis of rubella in pregnant woman who has been exposed to, or develops, rubella-like infection, is often Module 11C 11C - 35 difficult. The laboratory must be provided with a detailed history of, as routine screening tests are inadequate and additional testing to detect IgM antibody is required. False- negative results can occur if the specimen is drawn to soon after exposure. The pattern of antibody response to acute infection and re-infection will vary according to the test method used, and expert consultation may be required for interpretation of data. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth, Oxford university press, Third edition, 2000 Slide 11ɋ-1-58 Management of a Newborn Born to a Mother with Rubella The virus can be cultured for up to 1 year. The best specimens for viral recovery are from nasal pharyngeal swabs, conjunctival scrapings, urine, and CSF (in decreasing order of usefulness). Neonates with congenital rubella should be considered contagious until age 1 year thus isolated from other newborns at birth, unless nasopharyngeal and urine cultures are repeatedly negative but room in with their mothers. Breastfeeding is not contraindicated. For vaccinated lactating women: rubella vaccine virus can be isolated from breast milk; however, breastfeeding is not a contraindication to rubella vaccination because there is no evidence that the vaccine virus is in any way harmful to the infant. Tricia Lacy Gomella et al. Neonatology. Management, Procedures, On-Call Problems, Diseases, and Drugs. 5th Edition, Medical Publishing Division, 2004 Slide 11ɋ-1-59 Rubella: Prevention The objective of rubella vaccination programs is the prevention of congenital rubella syndrome. Two approaches to rubella vaccination have been used: universal vaccination and selective vaccination. Universal vaccination of young children male and female to interrupt transmission has led to a significant decline in reported cases of rubella and congenital rubella syndrome. High immunisation frequency must be achieved and maintained, and all susceptible women childbearing age should be identified and vaccinated. Effective Perinatal Care (EPC) 11C - 36 In the case of unknown vaccination history vaccination should follow childbirth, miscarriage, or termination of pregnancy, when the probability of pregnancy occurring within the next 30 days is low. Almost all vaccinated women show seroconversion, and side effects are mild. Pregnant women should not be given rubella vaccine, but there should be little concern if a pregnant woman is vaccinated unknowingly or if she becomes pregnant within 3 months after immunization. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth, Oxford university press, Third edition, 2000 National Collaborating Centre for Women's and Children's Health. Antenatal care: routine care for the healthy pregnant woman. London: RCOG Press; Oct 2003 Slide 11ɋ-1-60 Toxoplasmosis During pregnancy, toxoplasmosis can be transmitted across the placenta and may cause intrauterine death, foetal growth retardation, mental retardation, ocular defects, and blindness. The risk of transmission is mostly attributed to primary infection. According to reports, rates of seroconversion in non-immune pregnant women range from 2.4– 16/1000 in Europe and from 2–6/1000 in the USA. The risk of congenital disease is lowest (10-25%) when maternal infection occurs during the first trimester and highest (60-90%) when maternal infection occurs during the third trimester. However, congenital disease is more severe when infection is acquired in the first trimester. The overall risk of congenital infection from acute (first episode) T. gondii infection during pregnancy ranges from approximately 20 to 50%. Dunn D, Wallon M, Peyron F, Petersen E, Peckham C, Gilbert R. Mother-to-child transmission of toxoplasmosis: risk estimates for clinical counselling. Lancet 1999; 353:1829-33. Slide 11ɋ-1-61 Diagnosis of Toxoplasmosis during Pregnancy Confirm the diagnostic of toxoplasmosis if suspected during pregnancy. Toxoplasmosis usually is diagnosed by detecting specific antibody. The presence of elevated levels of specific IgM antibodies does not distinguish between recent infection and infection acquired in the past. Detection of - specific IgG antibodies has been used to Module 11C 11C - 37 determine the time of infection: a negative IgG test with a positive IgM usually indicates infection at least six months old. However, the interpretation of specific IgM positive results is complicated by the persistence of IgM antibodies up to 18 months after infection and by false-positive reactions in commercial tests. That is why, specific antibody test results should be confirmed by a Toxoplasmosis reference laboratory. Jones J., Lopez A., Wilson M. Congenital Toxoplasmosis. Am Fam Physician 2003; 67:2131-8,2145-6 Slide 11ɋ-1-62 Treatment of Toxoplasmosis during Pregnancy Spiramycine and Pyrimethamine are used to treat toxoplasmosis during pregnancy There is not strong evidence that the treatment prevent congenital infection or fetal damage. Piero Olliaro. Congenital toxoplasmosis. Clin Evid 2004;12:1058–1061 Slide 11ɋ-1-63 Management of a Newborn Born to a Mother with Toxoplasmosis The culture of the organism from blood cord, amniotic fluid or placental is possible but no available everywhere. Isolation of the organism from placental tissue correlates strongly with foetal infection. The diagnosis of congenital toxoplasmosis is most often based on clinical suspicion plus serologic tests. Congenital toxoplasmosis may be manifested during the neonatal period or later. Obstructive hydrocephalus, chorioretinitis, and intracranial calcifications are the classic triad of toxoplasmosis Infants with evident clinical disease may have disseminated illness or isolated CNS or ocular disease. Late sequelae are primarily related to ocular or CNS disease. Treatment of symptomatic infants consists of a combination of Pyrimethamine, Sulfadiazine, and Folic acid supplementation. Healthy newborns born to mothers with gestational toxoplasmosis can be treated with a preventive treatment until the parasite is isolated or during 4-weeks. If a diagnosis of congenital toxoplasmosis is established later, chemotherapy is continued as delineated Effective Perinatal Care (EPC) 11C - 38 for infants with sub clinical toxoplasmosis. Infant treated with Pyrimethamine and Sulfadiazine requires weekly blood counts, platelet counts, and urine microscopy to detect any adverse drug effects. Tricia Lacy Gomella et al. Neonatology. Management, Procedures, On-Call Problems, Diseases, and Drugs. 5th Edition, Medical Publishing Division, 2004 American Academy of Pediatrics, The American College of Obstetricians and Gynecologists. Guidelines for PERINATAL CARE. 5th Edition, October 2002 Slide 11ɋ-1-64 Toxoplasmosis: Prevention To prevent toxoplasmosis and other food-transmitted infections, food should be cooked to a safe temperature (71.1°C [160°F]) Health education for women of childbearing age should include information about preventing T. gondii transmission from food and soil. At the first prenatal visit, health care providers should educate pregnant women about food hygiene and avoiding exposure to cat faecal matter. Health care providers who care for pregnant women should be educated about two potential problems associated with T. gondii serology tests: 1) No test can determine precisely when initial T. gondii infection occurred. 2) In populations with a low incidence of T. gondii infection, a substantial proportion of positive IgM test results probably will be false positive. Preventing congenital toxoplasmosis. Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep 2000;49(RR-2):57-75. Slide 11ɋ-1-65 Malaria Malaria is a parasitic disease Severe malaria are mainly due to Plasmodium falciparum James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 The perception that countries of the WHO European Region are free from Module 11C 11C - 39 malaria has changed rapidly over the past decades. Since the early 1980s and throughout the decades to follow, the number of countries affected by malaria has increased from three to ten. At the beginning of the 1990s, the residual reservoir of malaria infection, aggravated by political and socio-economic situations, mass population migration, extensive development projects, and almost discontinued activities on malaria prevention and control constituted conditions favourable for malaria transmission. As a result, large-scale epidemics have broken out in Central Asia and Trans-Caucasian countries since 1995. Azerbaijan, Tajikistan and Turkey suffered explosive and extensive epidemics, while Armenia, Turkmenistan and Kyrgyzstan faced outbreaks on a smaller scale1. http://www.euro.who.int/malaria (11.03.2008) Slide 11ɋ-1-66 Diagnosis of Malaria during Pregnancy Pregnant women with symptomatic acute malaria are a high-risk group, and must receive effective antimalarials. Malaria in pregnancy is associated with low birth weight, increased anaemia and, in low-transmission areas, an increased risk of severe malaria. In high- transmission settings, despite the adverse effects on fetal growth, malaria is usually asymptomatic in pregnancy. There is insufficient information on the safety and efficacy of most antimalarials in pregnancy, particularly for exposure in the first trimester, and so treatment recommendations are different to those for non-pregnant adults. Organogenesis occurs mainly in the first trimester and this is therefore the time of greatest concern for potential teratogenicity, although nervous system development continues throughout pregnancy2. There are two methods in use for parasitological diagnosis are light microscopy and rapid diagnostic tests (RDTs). Light microscopy has the advantage of low cost and high sensitivity and specificity when used by well-trained staff. RDTs for detection of parasite antigen are generally more expensive, but the prices of some of these products have recently decreased to an extent that makes their deployment cost-effective in some settings. WHO, guidelines for the treatment of Malaria, 2006, WHO/HTM/MAL/2006/1108 1 http://www.euro.who.int/malaria (11.03.2008) 2 WHO, guidelines for the treatment of Malaria, 2006, WHO/HTM/MAL/2006/1108 Effective Perinatal Care (EPC) 11C - 40 Slide 11ɋ-1-67 Treatment of Malaria during Pregnancy The antimalarials considered safe in the first trimester of pregnancy are quinine, chloroquine, proguanil, pyrimethamine and sulfadoxine–pyrimethamine. Of these, quinine remains the most effective and can be used in all trimesters of pregnancy including the first trimester. In reality women often do not declare their pregnancies in the first trimester and so, early pregnancies will often be exposed inadvertently to the available firstline treatment. Inadvertent exposure to antimalarials is not an indication for termination of the pregnancy. There is increasing experience with artemisinin derivatives in the second and third trimesters (over 1000 documented pregnancies). There have been no adverse effects on the mother or fetus. The current assessment of benefits compared with potential risks suggests that the artemisinin derivatives should be used to treat uncomplicated falciparum malaria in the second and third trimesters of pregnancy, but should not be used in the first trimester until more information becomes available. Lactating woman should receive standard antimalarial treatment (including ACTs) except for tetracylines and dapsone, which should be withheld during lactation.3. WHO, guidelines for the treatment of Malaria, 2006, WHO/HTM/MAL/2006/1108 WHO, Pregnancy, Childbirth, Postpartum and Newborn Care: A guide for essential practice. Geneva, 2006. Slide 11ɋ-1-68 Management of a Newborn Born to a Mother with Malaria Congenital malaria is rare. The clinical symptoms are similar to neonatal sepsis. There no evidence that malaria is transmitted through breast milk. The greatest risk to an infant to be infected is due to mosquito bite. Ruth A. Lawrence, Robert M. Lawrence. BREASTFEEDING. A guide for medical profession. 6th Edition, 2005 3 WHO, guidelines for the treatment of Malaria, 2006, WHO/HTM/MAL/2006/1108 Module 11C 11C - 41 Slide 11ɋ-1-69 Malaria: Prevention Prevention is based on: x Evaluating the risk of exposure to infection x Preventing mosquito bites by using DEET mosquito repellent, bed nets, and clothing that covers most of the body x Preventive treatment with antimalarial drugs of vulnerable groups such as pregnant women, who receive intermittent preventive treatment. No prophylactic regimen gives complete protection. Effectiveness of any given medication varies by the region of the world. Effectiveness also varies from year to year, so current information is essential. Travellers from non-endemic countries should take precautions against acquiring malaria when they visit a malaria risk area. Malaria. Control and Prevention. Centers for Disease Control and Prevention. April 23, 2004 WHO, Pregnancy, Childbirth, Postpartum and Newborn Care: A guide for essential practice. Geneva, 2006. Slide 11ɋ-1-70 Trichomoniasis Untreated trichomoniasis can cause maternal urethritis and cystitis, frequently asymptomatic. During pregnancy vaginal trichomoniasis is associated with premature rupture of membranes and preterm labour. Detection of Trichomonas vaginalis (by wet mount) had no significant associations with preterm delivery. Forna F, Gülmezoglu AM. Interventions for treating trichomoniasis in women. Cochrane Database of Systematic Reviews 2003, Issue 2 Meis PJ, Goldenberg RL et al. The preterm prediction study: significance of vaginal infections. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network Am J Obstet Gynecol. 1995 Oct;173(4):1231-5 Effective Perinatal Care (EPC) 11C - 42 Slide 11ɋ-1-71 Diagnosis and Treatment of Trichomoniasis during Pregnancy Treatment of pregnant women with asymptomatic trichomoniasis does not prevent preterm delivery. Routine screening and treatment of asymptomatic pregnant women for this condition cannot be recommended. Women with symptoms should be treated with metronidazole. Recommended treatment regimens are: x Oral Methronidazole 2 g in a single administration, OR x Oral Methronidazole 500 mg 2 times a day for 7 days Klebanoff M et al. Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection. N Engl J Med. 2001 Aug 16;345(7):487-93 Kigozi GG et al. Treatment of Trichomonas in pregnancy and adverse outcomes of pregnancy: a subanalysis of a randomized trial in Rakai, Uganda. Am J Obstet Gynecol. 2003 Nov;189(5):1398-400. Gülmezoglu AM. Interventions for trichomoniasis in pregnancy. Cochrane Database of Systematic Reviews 2002, Issue 3. Centers for Disease and Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR 2006;55(RR11):1-94 Slide 11ɋ-1-72 Infection which do not Affect Pregnancy: Vaginal Candidiasis Diagnosis of vaginal candidiasis is based on microscopic examination of vaginal discharges (identifying of pseudohyphae and/or yeast cells). Culture confirmation is important. Screening for vaginal candidiasis is not recommended. Infection can be treated with oral fluconazole or topical clotrimazole, miconazole, butaconazole, terconazole, tioconazole or nystatin, but infection is frequently recurrent, drugs are not cheap, and the most important that foetal effects of oral treatment are unknown. Women do not need to be hospitalized or isolated from other women. Module 11C 11C - 43 Prevention for women: detect early and treat locally any infection in the mouth, oesophagus and urinary bladder. The newborn needs to room-in with his/her mother and be breastfed. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care. Copenhagen, 2002 . James Chin. An official report of American Public Health Association. Control of Communicable Disease Manual. 17th Edition. 2000 Slide 11ɋ-1-73 Characteristics of Effective Screening Program Never screen for infections if the result of such screening has no practical value in local conditions, i.e. if treatment for those with positive results is impossible due to limited resources. It is necessary to use internationally accepted definitions in diagnosis: for example, presence of bacteria does not meant presence of infection. According to the national policies different screening programs exist in different countries: . Recommended screening program in Australia: x Rubella IgG x Hepatitis B surface antigen x Syphilis x HIV antibody x Urine culture x Vaginal/rectal swabs for group B streptococcal carriage Not recommended tests for antenatal screening in Australia: - Cytomegalovirus IgG and IgM x No treatment or vaccine available for seronegative women x IgM is an unreliable marker of recent (primary) infection - Toxoplasmosis IgG and IgM x Primary infection during pregnancy is rare in Australia x IgM is unreliable marker of recent (primary) infection x Routine screening is recommended in some countries - Hepatitis C (virus antibodies) x Infection is rare and transmission to foetus is uncommon x No vaccine or treatment is available Effective Perinatal Care (EPC) 11C - 44 - Urine test for Chlamydia DNA x Incidence in population is generally low in Australia x Routine antenatal screening is expensive for some patients Gwendolyn L Gilbert. Medical Journal of Australia. 2002 176 5: 229-236 Recommended screening program in the UK x Asymptomatic bacteriuria x Syphilis x Rubella x HIV x HBsAg National Collaborating Centre for Women's and Children's Health. Antenatal care: routine care for the healthy pregnant woman. London: RCOG Press; 2003 Slide 11ɋ-1-74 Conclusions Only hospitalize a woman for an infection if it is the only place where she can receive treatment: admission to a hospital may pose a risk to the mother, baby and others. x Never isolate a pregnant woman from her baby or from other women unless such contact poses a genuine risk to her or others. x Never use maternal infection as a pretext for interfering with breast- feeding unless there is a risk to the baby from such contact. x The current high prevalence of sexually transmitted infections in women in the European Region underlines the necessity for health workers to use universal precautions when dealing with body fluids. x Different countries will have different priorities regarding identification and treatment of infections: it is impossible to expect implementation of universal precautions regarding infections due to the limited resources in healthcare sector. Approaches to infection control and treatment will vary at the local level. WHO Euro. Essential Antenatal, Perinatal and Postpartum Care, Copenhagen, 2002 . Module 11C 11C - 45 Module 11ɋ Infections in Pregnancy, Childbirth and Postpartum Part II Effective Perinatal Care (EPC) 11C - 46 Module 11C 11C - 47 Slide 11ɋ-2-1 Nosocomial Infections The problem and possible ways of nosocomial infections prevention will be discussed during the second part of this module. Slide 11ɋ-2-2 Nosocomial Infections (Hospital-Acquired Infections) Nosocomial infections may also be considered either endemic or epidemic. Endemic infections are most common. Epidemic infections occur during outbreaks, defined as an unusual increase above the baseline of a specific infection or infecting organism. Prevention of hospital-acquired infections. A PRACTICAL GUIDE. 2nd edition, WHO, 2002 Slide 11ɋ-2-3 Nosocomial Infections: Frequency Nosocomial infections occur worldwide and affect both developed and resource- poor countries. Infections acquired in health care settings are among the major causes of death and increased morbidity among hospitalized patients. They are a significant burden both for the patient and for public health. Prevention of hospital-acquired infections. A PRACTICAL GUIDE. 2nd edition, WHO, 2002. Effective Perinatal Care (EPC) 11C - 48 Slide 11ɋ-2-4 Nosocomial Infections: Reservoirs and Transmission (1) Bacteria that cause nosocomial infections can be acquired in several ways: 1. The permanent or transient flora of the patient (endogenous infection). Bacteria present in the normal flora cause infection because of transmission to sites outside the natural habitat (urinary tract), damage to tissue (wound) or inappropriate antibiotic therapy that allows overgrowth. 2. Flora from another patient or member of staff (exogenous cross-infection). Bacteria are transmitted between patients: x Through direct contact between patients (hands, saliva droplets or other body fluids) x In the air (droplets or dust contaminated by a patient’s bacteria) x Via staff contaminated through patient care (hands, clothes, nose and throat) who become transient or permanent carriers, subsequently transmitting bacteria to other patients by direct contact during care x Via objects contaminated by the patient (including equipment), visitors or other environmental sources (e.g. water, other fluids, food) 3. Flora from the health care environment (endemic or epidemic exogenous environmental infections). Several types of micro organisms survive well in the hospital environment: x In water, damp areas, and occasionally in sterile products or disinfectants x In items such as linen, equipment and supplies used in care x In food x In fine dust and droplet nuclei generated by coughing or speaking Prevention of hospital-acquired infections. A PRACTICAL GUIDE. 2nd edition, WHO, 2002 Slide 11ɋ-2-5 Nosocomial Infections: Reservoirs and Transmission (2) People are the main reservoir and source, main transmitter and receptor for micro organisms. Prevention of hospital-acquired infections. A PRACTICAL GUIDE. 2nd edition, WHO, 2002 Module 11C 11C - 49 Slide 11ɋ-2-6 Nosocomial Infections: Prevention (1) Prevention of nosocomial infections requires an integrated, monitored, programme which includes several key components listed on the slide. Prevention of hospital-acquired infections. A PRACTICAL GUIDE. 2nd edition, WHO, 2002 Slide 11ɋ-2-7 Nosocomial Infections: Prevention (2) Infection control is the responsibility of all health care professionals — doctors, nurses, therapists, pharmacists, engineers and others. Prevention of hospital-acquired infections. A PRACTICAL GUIDE. 2nd edition, WHO, 2002 Slide 11ɋ-2-8 Hands Hygiene: Importance All bacteria recovered from the hands can be divided into two categories: transient and resident. Resident floras, which are attached to deeper layers of the skin, are more resistant to removal. In addition, resident flora (e.g., coagulase-negative staphylococci and diphtheroids) are less likely to be associated with such infections. Transient floras, which colonize the superficial layers of the skin, are more amenable to removal by routine hand washing. They are often acquired by Health Care Workers (HCWs) during direct contact with patients or contact with contaminated environmental surfaces within close proximity of the patient. The importance of hands in the transmission of hospital infections has been well demonstrated, and can be minimized with appropriate hand hygiene. Effective Perinatal Care (EPC) 11C - 50 Prevention of hospital-acquired infections. A PRACTICAL GUIDE. 2nd edition, WHO, 2002 Guideline for Hand Hygiene in Health-Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Centers for Disease Control and Prevention, October 25, 2002, Vol. 51, No. RR-16. Slide 11ɋ-2-9 Why Personnel Don’t Wash Their Hands? The question “Why personnel do not wash their hands?” was studied in the trial of Wharton KN, Karlowicz MG in 1998. Additional factors for poor adherence with hand hygiene: o Hand washing agents cause irritation and dryness, o Sinks are inconveniently located or there is a shortage of sinks, o Understaffing/overcrowding, o Patient needs take priority, o Hand hygiene interferes with health-care worker relationships with patients, o Low risk of acquiring infection from patients, o Lack of knowledge of guidelines/protocols, o Not thinking about it/forgetfulness, o No role model from colleagues or superiors, o Scepticism regarding the value of hand hygiene, o Disagree with the recommendations, o Lack of scientific information of definitive impact of improved hand hygiene on health- care–associated infection rates. Pittet D. Improving compliance with hand hygiene in hospitals. Infect Control Hosp Epidemiol 2000;21:381–6. Slide 11ɋ-2-10 Organisation of Appropriate Hands Hygiene Several strategies for promotion of hand hygiene in hospitals have been published. These strategies require education, motivation, or system change. Certain strategies are based on epidemiologic evidence, others on the authors’ and other investigators’ experience and review of current knowledge. Some strategies may be unnecessary in certain circumstances, but may be helpful in others. In Module 11C 11C - 51 particular, changing the hand-hygiene agent could be beneficial in institutions or hospital wards with a high workload and a high demand for hand hygiene when alcohol-based hand rubs are not available. Ultimately, adherence to recommended hand hygiene practices should become part of a culture of patient safety where a set of interdependent quality elements interact to achieve a shared objective. Guideline for Hand Hygiene in Health-Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Centers for Disease Control and Prevention, October 25, 2002, Vol. 51, No. RR-16. Slide 11ɋ-2-11 Training and Motivation of Personnel Training of personnel: x Different trainings for different groups of medical staff (schedule of the trainings should be based on needs assessment); x Train at orientation and after on continuous basis; x Development of a protocol on hygiene for hands and antiseptic; x Practical seminars, trainings on hand washing technique; Guideline for Hand Hygiene in Health-Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Centers for Disease Control and Prevention, October 25, 2002, Vol. 51, No. RR-16. Centers for Disease Control and Prevention Slide 11ɋ-2-12 Technique of Hands Washing (1) Hands should be decontaminated before direct contact with patients and after any activity or contact that contaminates the hands, including following the removal of gloves. While alcohol hand gels and rubs are a practical alternative to soap and water, alcohol is not a cleaning agent. Hands that are visibly dirty or potentially grossly contaminated must be washed with soap and warm water and dried thoroughly. Hand preparation increases the effectiveness of decontamination. Improper drying can re-contaminate hands that have been washed. Wet surfaces transfer organisms more effectively than dry ones and inadequately dried hands are Effective Perinatal Care (EPC) 11C - 52 prone to skin damage. Disposable paper hand towels of good quality should be used to ensure hands are dried thoroughly. Hand towels should be conveniently placed in wall mounted dispensers close to hand washing facilities. UK’s Royal College of Nursing, 2006 These materials are available on the Web-site: www.rcn.org.uk/resources/mrsa/healthcarestaff/mrsa/handhygiene.php Slide 11ɋ-2-13 Why Use the Special Technique? Places which most usually stay not washed are marked by yellow and red on the slide: web spaces, phalanxes, palmer folds, and rare area of the thumb. Slide 11ɋ-2-14 Technique of Hands Washing (2) An example of the poster with correct technique of hand washing. Such posters need to be placed near each hand washing station. UK’s Royal College of Nursing, 2006 These materials are available on the Web-site: www.rcn.org.uk/resources/mrsa/healthca restaff/mrsa/handhygiene.php Slide 11ɋ-2-15 Hand Decontamination: Procedures (1) Differential nosocomial infection risk by patient and interventions Module 11C 11C - 53 Risk of infection Type of patients Type of procedures Minimal Not immunocompromised; no significant underlying disease Non-invasive No exposure to biological fluids Recommended hygienic hand antiseptic technique: x Put 3-5 ml of alcohol antiseptic on the hands and rub until dry using appropriate technique (it is not needed to dry the hands with towel). It is important to follow the time-rule: hands should be wet with antiseptic not less than 15 seconds. Prevention of hospital-acquired infections. A PRACTICAL GUIDE, 2nd edition, WHO, 2002. Rotter ML, Arguments for alcoholic hand disinfection. J Hosp Infect. 2001 Aug;48 Suppl A:S4-8 Slide 11ɋ-2-16 Hand Decontamination: Procedures (2) Differential nosocomial infection risk by patient and interventions Risk of infection Type of patients Type of procedures Medium Infected patients, or patients with some risk factors (age, neoplasm) Exposure to biological fluids or invasive non-surgical procedure (e.g. peripheral venous catheter, introduction of urinary catheter) Prevention of hospital-acquired infections. A PRACTICAL GUIDE, 2nd edition, WHO, 2002 Effective Perinatal Care (EPC) 11C - 54 Slide 11ɋ-2-17 Hand Decontamination: Procedures (3) Differential nosocomial infection risk by patient and interventions Risk of infection Type of patients Type of procedures High Severely immunocompromised patients (<500 White Blood Cells per ml), multiple trauma, severe burns, organ transplant Surgery or high-risk invasive procedures (e.g. central venous catheter, manual removal of placenta, endotracheal intubation) Using a brush or soap? A study found twice as many colonies of S. hominis, S. aureus, gram-negative bacillus, Candida spp. on the hands of medical personnel who used a brush for hand washing. Prevention of hospital-acquired infections. A PRACTICAL GUIDE, 2nd edition, WHO, 2002 Larson E: Skin hygiene and infection prevention. Clin Infect Dis 29, 1999 Slide 11ɋ-2-18 Use of Gloves It is recommended that health workers wear gloves to: x Reduce the risk of personnel acquiring infections from patients, x Prevent health-care worker flora from being transmitted to patients, and x Reduce transient contamination of the hands of personnel by flora that can be transmitted from one patient to another. Recent studies indicate that improvements have been made in the quality of gloves; hands should be decontaminated or washed after removing gloves. Gloves should not be washed or reused. Module 11C 11C - 55 Sensitivity to latex may occur, and the occupational health programme must have policies to evaluate and manage this problem. Guideline for Hand Hygiene in Health-Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA. Hand Hygiene Task Force. Centers for Disease Control and Prevention. October 25, 2002, Vol. 51, No. RR-16. Prevention of hospital-acquired infections. A PRACTICAL GUIDE, 2nd edition, WHO, 2002 Slide 11ɋ-2-19 Antibiotic Prophylaxis: When? Prophylaxis with antibiotics in preterm prelabour rupture of membranes and prolonged membrane rupture aims at: x Decreasing maternal infection, x Prevention of newborn infection (pneumonia, sepsis), x Decreasing newborn admission to NICU, x Prolongation of latent stage in preterm labour. Preterm premature rupture of membranes: x It is recommended to use macrolides: erythromycin 500 mg each 8 hours; clindamycin 900 mg each 8 hours. x Treatment with erythromycin (500 mg each 8 hours) has low complications rate versus other antibiotics. Meta-analysis of the 11 RCTs fails to demonstrate a clear overall benefit from prophylactic antibiotic treatment for preterm labour with intact membranes on neonatal outcomes, and instead raises concerns about increased neonatal mortality for those who received antibiotics. This treatment (i.e. the use of antibiotics) cannot therefore be currently recommended for routine practice. Prolonged membranes rupture > 18 hours at 37 or more weeks of pregnancy (unknown GBS status): x Penicillin G should be administered as 3g IV followed by 1.5g IV every 4 hours until birth. (RCOG, 2003) Kenyon S. et al. Antibiotics for preterm premature rupture of membranes (Cochrane Review), Cochrane Library, Issue 3, 2002 King J, Flenady V. Prophylactic antibiotics for inhibiting preterm labour with intact membranes (Cochrane Review). The Cochrane Database of Systematic Reviews 2002, Issue 4. Prevention of early onset neonatal group B streptococcal disease. Royal College of Obstetricians Gynaecologists. Guideline N 36, November 2003 Effective Perinatal Care (EPC) 11C - 56 Slide 11ɋ-2-20 Ineffective Practices Detergent and water are adequate for cleaning surfaces in non-patient care areas (e.g., administrative offices). Avoid large-surface cleaning methods that produce mists or aerosols, or disperse dust in patient-care areas. Follow proper procedures for effective uses of mops, cloths, and solutions. Guidelines for Environmental Infection Control in Health-Care Facilities Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) U.S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC) Atlanta, 2003 Do not routinely apply prophylactic topical antimicrobial or antiseptic ointment or cream to the insertion site of peripheral venous catheters. [A] Replace the catheter-site dressing when it becomes damp, loosened, or soiled or when inspection of the site is necessary. [A] Guidelines for the Prevention of Intravascular Catheter-Related Infections, CDC, August 9, 2002. Vol. 51, No. RR-10. Do not remove hair preoperatively unless the hair at or around the incision site will interfere with the operation. Protect with a sterile dressing for 24 to 48 hours postoperatively an incision that has been closed primarily. No recommendation to cover an incision closed primarily beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision. Alicia J. Mangram, MD; Teresa C. Horan, MPH, CIC et al. GUIDELINE FOR PREVENTION OF SURGICAL SITE INFECTION The Hospital Infection Control Practices Advisory Committee. Infection control and hospital epidemiology1999, Vol. 20, #4:247-278 Slide 11ɋ-2-21 Restriction of Relatives’ Visits Restricting visits is a practice with no proven effectiveness. Many hospitals invoke concern about infection as the reason for restricting or forbidding visits, although studies using concurrent and historical control groups have been unable to detect any adverse effect of this on infant colonization rates. Murray W. Enkin et al, A guide to Module 11C 11C - 57 effective care in pregnancy and childbirth, Oxford University Press, 3-rd ed, 2000 Slide 11ɋ-2-22 Wearing Masks and Caps Caps and masks should be abolished, and aprons and gowns used only by those who wish to protect their own clothing from the various soiling from the babies. Masks of cotton wool, gauze, or paper are ineffective. Paper masks with synthetic material for filtration are an effective barrier against micro organisms. Masks are used in various situations. Mask requirements differ for different purposes: x Patient protection: staff wears masks to work in the operating room, to care for immuno-compromised patients, to puncture body cavities. A surgical mask is sufficient. x Staff protection: staff must wear masks when caring for patients with airborne infections, or when performing bronchoscopies or similar examination. A high- efficiency mask is recommended. x Patients with infections which may be transmitted by the airborne route must use surgical masks when outside their isolation room. Murray W. Enkin et al, A guide to effective care in pregnancy and childbirth, Oxford University Press, 3-rd ed, 2000 Prevention of hospital-acquired infections. A PRACTICAL GUIDE, 2nd edition, WHO, 2002 Slide 11ɋ-2-23 Ultraviolet Germicidal Irradiation As a supplemental air-cleaning measure, Ultraviolet Germicidal Irradiation (UVGI) is effective in reducing the transmission of airborne bacterial and viral infections in hospitals, but it has only a minimal inactivating effect on fungal spores. Two systems of UVGI have been used in health-care settings – duct irradiation and upper-room air irradiation. Effective Perinatal Care (EPC) 11C - 58 Regular maintenance of UVGI systems is crucial and usually consists of keeping the bulbs free of dust and replacing old bulbs as necessary. UVGI tubes should be changed and cleaned according to the instructions of the manufacturer. In settings that use UVGI systems, education of healthcare workers should include: 1. Basic principles of UVGI systems (mechanism and limitations). 2. Potential hazardous effects of UVGI if overexposure occurs. 3. Potential for photosensitivity associated with certain medical conditions or use of certain medications. 4. The importance of maintenance procedures and record-keeping. In settings that use UVGI systems, patients and visitors should be informed of the purpose of UVGI systems and be warned about the potential hazards and safety precautions. Guidelines for Environmental Infection Control in Health-Care Facilities Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) U.S. Department of Health and Human Services Centers for Disease Control and Prevention (CDC), Atlanta, 2003 Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 CDC, December 30, 2005, Vol. 54, No. RR-17 Slide 11ɋ-2-24 Use of Disinfectants Routine use of disinfectants has no proven effectiveness. There is evidence that bacterial contamination of the floor reaches its initial level 2 hours after cleaning, either with disinfectant or without it. Disinfectants should not be sprayed. There is no evidence that sprayed formalin or formaldehyde decreases risk of infection. It is recommended to use careful cleaning and mechanical tidying instead of disinfectants spraying. Guidelines for Environmental Infection Control in Health-Care Facilities: Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC), June 2003 Module 11C 11C - 59 Slide 11ɋ-2-25 Conclusions Main recommendations for infection control in obstetric hospitals. Effective Perinatal Care (EPC) 11C - 60 Module 12ɋ Preterm Labour Effective Perinatal Care (EPC) 12C - 2 Module 12C 12C - 3 Slide 12ɋ-1 Preterm Labour Learning objectives: x Learn and be able to use obstetric technologies correctly, which could improve perinatal outcomes in preterm newborns x Understand problems with early diagnostic methods and preventative methods for preterm labour x Critically assess the use of tocolytics in cases of threatened preterm labour x Understand the recommended use of corticosteroids x Understand the basic principles of managing low birth weight newborns Slide 12ɋ-2 Preterm Labour (1) Preterm labour accounts for 65% of neonatal deaths and 50% of neurological disabilities in childhood. Spontaneous preterm labour or prelabour rupture of the membranes accounts for 80% of preterm deliveries. Prematurity rates have not changed in recent decades. Preterm labour are those that occur before 37 weeks of gestation. The minimal gestational age is not specified, but 23-24 weeks of gestation (500 g birth weight) is accepted by many countries. Preterm labour is: x Labour between 20 and 37 weeks AND x Clinically documented uterine contractions (4 in 20 minutes or 8 in 60 minutes) AND o Ⱥ. ruptured membranes, or o ȼ. intact membranes and cervix dilated more then 2 cm, or o ɋ. intact membranes and cervix effaced more then 80%, or o D. intact membranes and dynamic structural changes of the cervix. Information and Statistics Division. Scottish stillbirth and infant death report 1996 Edinburgh: NHS in Scotland, 1997 Institute for Clinical Systems Improvement (ICSI). Preterm birth prevention. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI), August, 2002 Janet Tucker. Epidemiology of preterm birth. BMJ 2004;329:675-678 Parry G, et al. Lancet 2003, 361, 1789-91. Andrew H Shennan. Recent developments in obstetrics. Clinical review. BMJ, 2003, 327, 604-608. Effective Perinatal Care (EPC) 12C - 4 Slide 12ɋ-3 Preterm Labour (2) Despite the fact that all deliveries before 37 weeks of gestation are preterm deliveries, deliveries before 32 weeks (2% of all deliveries) are the cause of the largest share of neonatal morbidity and mortality. Martin JA, Hamilton BE, Ventura SJ, et al. Births: Final data for 2001 National Vital Statistics Report; 2002;51(2). National Center for Health Statistics. Goldenberg RL. Management of Preterm Labor. Obstet Gynecol 2002 Slide 12ɋ-4 Mortality, Birth Weight and Gestational Age Data from USA National Center for Health Statistics, 2002. National Vital Statistics Report. USA National Center for Health Statistics. 2002, 51(2). Martin JA, Hamilton BE, Ventura SJ, et al. Births: Final data for 2001 Goldenberg RL. Management of Preterm Labor. Obstet Gynecol, 2002 Slide 12ɋ-5 What Facilitated a Decrease of Mortality and Morbidity in Preterm Labour? There are two categories of strategies used to reduce adverse outcomes associated with prematurity: those intended to prevent or delay preterm birth, and those intended to reduce prematurity- associated morbidity and mortality. Among them, however, the most successful is regionalization of perinatal care, which ensures that most preterm infants are delivered at a newborn intensive care unit with appropriate facilities and trained personnel. Effective neonatal interventions include improved methods of mechanical ventilation, exogenous-surfactant therapy, liberal antibiotic treatment, and appropriate fluid and electrolyte management. Module 12C 12C - 5 Effective obstetrical interventions include the use of prenatal corticosteroids for foetal maturation and intrapartum antibiotics to reduce neonatal sepsis, as well as prevention and prompt treatment of foetal hypoxia. Goldenberg RL, Rouse DJ. Prevention of premature birth. N Eng J Med, 1998, 339, 313-320. Slide 12ɋ-6 Early Neonatal Mortality and Birth Weight by Level of Medical Facility This table shows the difference in the survival rate of preterm babies regarding the level of facility providing care. Early neonatal mortality in babies with birth weights of 500-750 g is 86%0 in 3rd level maternities (Perinatal Centers - Ⱥ), 148%0 for 2nd level (ȼ) and 226%0 if care is provided by a 1st level facility (ɋ). The difference in levels of early neonatal mortality in the babies with birth weights of between 1000-1500 g. is 10 times greater: 5% in 3rd level facilities and 54 ‰ - in 1st level facilities. National Vital Statistics Report. US National Center for Health Statistics. 2002, 51(2). "To improve access to appropriate care for all women regardless of their initial choice of maternity unit, many countries have implemented regionalization policies to transfer high-risk pregnant women before very preterm delivery to level III maternity units. In the 1990s, France put into place a regionalization policy which was made official in 1998. Maternity hospitals are required to sign conventions with a reference level III maternity unit and organise maternal transfers to these units. Three levels of care were defined: the first level provides care for normal pregnancies and healthy newborns. The second level cares for pregnancies at moderate risk and is subdivided into two categories, A and B. Level IIB has the capacity to provide mechanical ventilation for less than 24 h. The third level maternity unit is a regional reference centre with neonatal intensive care services. These recommendations are similar to those issued by the American Academy of Pediatrics and those in many other European countries." Jennifer Zeitlina, Cletus D. Gwanfogbea , Dominique Delmasa, Hugo Pilkingtona, Jean-Louis Chabernaudd and Emile Papiernik. Risk factors for not delivering in a level III unit before 32 weeks of gestation: results from a population-based study in Paris and surrounding districts in 2003. "The United States aims to have 90% of infants <1500 g delivered in perinatal centers, a national health objective. In Australia the National Health and Medical Research Council (NHMRC) recommends that births < 33 weeks gestation should occur in perinatal centers. Regionalization of Australian perinatal services aims to fulfill the National Health and Medical Research Council (NHMRC) guideline by concentrating a critical mass of high-risk infants at selected facilities which develop the expertise to give each infant the best chance of survival." CL Roberts, CS Algert, B Peat and DJ Henderson-Smart. Trends in place of birth for preterm infants in New South Wales,1992–2001. J. Paediatr. Child Health (2004) 40, 139–143 Effective Perinatal Care (EPC) 12C - 6 "We evaluated the extent to which the regionalization of perinatal care in Washington State has succeeded in concentrating high-risk pregnancies in technologically appropriate referral centers and in reducing differences in neonatal outcome among hospitals…. Regionalization of perinatal care has been widely adopted as a strategy to bring high-risk mothers and babies to specialized perinatal centers to reduce regional differences in the availability of sophisticated perinatal care. A major intent of regionalizing perinatal care is to minimize differences in outcome attributable to the geographic location." Roger A. Rosenblatt, Jennifer A. Mayfield, L. Gary Hart, Laura M. Baldwin. Outcomes of Regionalized Perinatal Care in Washington State. West J Med. 1988 July; 149(1): 98–102. "Introduction of public health care principles in the system of reproductive health care in Belarus started in the middle of 90-ies. The first step was the regionalisation of perinatal and neonatal care, establishment of 2nd and 3rd level centres for pregnant women of “high risk” and severely ill new-born, and the system of reanimation care including mobile teams. Both on the account of the Ministry of Health and on the account of sponsor investments the above centres were equipped with the necessary medical equipment, training for medical staff were carried out and is regularly organised". Zinaida A. Sevkovskaia, Specialist of Reproductive Health Department of Scientific Research Institute for Mother&Child Care of Republic of Belarus. Dynamics of Reproductive Health in Belarus after Cairo Conference. Slide 12ɋ-7 Use of Corticosteroids in Preterm Labour Nomogram shows evidence for positive effects of glycocorticoids in preterm labour. Crowley P. Prophylactic corticosteroids for preterm birth. The Cochrane Database Syst Rev, 2003, Issue 3. Slide 12ɋ-8 Antibiotics Group B Streptococcus (Streptococcus agalactiae) is recognised as the most frequent cause of severe early onset infection (less than seven days of age) in newborn infants. The incidence of early- onset GBS in the UK is 0.5/1000. Women are screened for risk factors, and intrapartum antibiotic prophylaxis is offered to all women with recognised risk factors for early onset GBS disease. Risk factors are: Module 12C 12C - 7 x Previous baby affected by GBS x GBS bacteriuria detected during the current pregnancy x Preterm labour x Prolonged rupture of the membranes x Fever during labour Intrapartum antibiotic prophylaxis is 80% effective in preventing early-onset GBS. Mortality from early-onset GBS disease in the UK is 6% in term infants and 18% in preterm infants. Intrapartum antibiotic prophylaxis will not prevent all deaths. Even when treated appropriately some infants will still die of early-onset disease, particularly when the disease is well established prior to birth. If one makes the assumption that the effect of antibiotic prophylaxis on neonatal death from GBS is equivalent to its effect on GBS disease, then to prevent one neonatal death from GBS would require at least 7000 colonised women to be given intrapartum antibiotic prophylaxis, which would require at least 24,000 women to be screened. One of the recommended regimens: x 3 g of Benzylpenicillin at labour onset, and then 1.5 g 4-hourly until the delivery. This dosage is based on traditions rather than on evidence. There are other regimens of the use of antibiotics: x 2.4 g of Benzylpenicillin at labour onset, and than 1.2 g 4-hourly until the delivery; x 5 g of Benzylpenicillin at labour onset, and than 2.5 g 4-hourly until the delivery. Broad spectrum antibiotics should not be used because of the high potential risk of early neonatal sepsis cased by gram-negative bacteria. Royal College of Obstetricians and Gynecologists (RCOG). Prevention of yearly onset neonatal group B streptococcal disease. RCOG Press, November 2003, Guideline No. 36. Slide 12ɋ-9 How to Prevent Preterm Labour? Many prophylactic and treatment measures aimed at decreasing the incidence of preterm labours and their consequences were and are still used in medical practice. Are they effective? Does treatment of preterm deliveries exist? What is a threatened preterm labour? How to differentiate between the onset of labour and a physiological condition in pregnant women (Braxston - Hicks contractions)? All these questions will be discussed during the current session. Effective Perinatal Care (EPC) 12C - 8 Slide 12ɋ-10 Risk Factors for Preterm Labour A history of preterm labour is the most significant risk factor for the delivery of a preterm babies: the risk is 14.3% with a history of one preterm delivery, and 28% with a history of 2 preterm deliveries. Other risk factors are: hydroamnion, vaginal haemorrhage in the 1st trimester, short interval between deliveries, domestic violence, etc. Unfortunately, the majority of these factors cannot predict preterm labour, because of low prognostic sensitivity (35-60%) and prognostic value (15-30%) Edwin Chandraharan, Sabaratnam Arulkumaran. Recent advances in management of preterm labor. J Obstet Gynecol India Vol. 55, No. 2: March/April 2005 Pg 118- 124 Slide 12ɋ-11 What Was Used to Prevent Preterm Labour? Many interventions aimed to decrease the number of preterm deliveries were proposed, such as bed rest, hospitalization at “critical term”, barotherapy, plasmopheresis.,etc. Unfortunately, none of them proved their effectiveness in clinical trials. A multicentre randomised controlled trial (Villar J, Ba'aqeel H, Piaggio G, 2001) compared the standard model of antenatal care to a new model that emphasised actions known to be effective in improving maternal or neonatal outcomes and had fewer clinic visits. The primary outcomes were low birthweight (<2500 g), pre- eclampsia/eclampsia, severe postpartum anaemia (<90 g/L haemoglobin), and treated urinary- tract infection. There was an assessment of quality of care and an economic evaluation. Under the new model (n=12568) women had a median of five visits compared to eight within the standard model (n=11958). The groups had similar rates of low birthweight (new model 7.68% vs standard model 7.14%; stratified rate difference 0.96 [95% CI -0.01 to 1.92]), postpartum anaemia (7.59% vs 8.67%; 0.32), and urinary-tract infection (5.95% vs 7.41%; -0.42 [-1.65 to 0.80]). There were negligible differences between groups for several secondary outcomes. Bed rest has not been shown to reduce the incidence of preterm birth. Compared with women receiving standard care, women at high risk who received enhanced social support during pregnancy experienced similar rates of stillbirths, neonatal deaths, preterm deliveries, low-birth weight babies and babies with a low Apgar score. Balanced energy and protein nutrition supplementation reduces the incidence of small for- gestational-age births and may reduce the perinatal mortality rate. It has no apparent effect on Module 12C 12C - 9 the mean length of gestation. Public health programs offering nutritional supplements should not be based on the premise that they will reduce rates of preterm births. On the basis of available evidence, any prohibition of sexual activity is inappropriate. Confinement to bed rest at home or hospitalization during pregnancy may result in great financial and social costs for pregnant women and their families. Antenatal hospitalization is often a disruptive and stressful experience involving the separation of the woman from their families at a time of great anxiety. In addition, adoption of this policy has brought substantial costs to the health service. Many clinicians prescribe betamimetic drugs to prevent uterine contractions in women who are considered to be at an increased risk of preterm labour. Trials of prophylactic betamimetics have failed to detect any reduction in the risk of preterm birth, low birth weight, or perinatal mortality. The effects of routine magnesium supplementation on preterm labour have been addressed in a number of trials, but the results are inconclusive. Calcium supplementation has demonstrated no reduction in the risk of preterm delivery. Regular intramuscular injection of 17Į-hydroxyprojesteron caproate may reduce the incidence of preterm labour and preterm births in women considered to be at a high risk of preterm labour, but they have not been shown to decrease perinatal mortality and morbidity. Murray W. Enkin et al, A guide to effective care in pregnancy and childbirth. Oxford University Press. 3rd edition. 2000 Villar J, Ba'aqeel H, Piaggio G. WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care. Lancet, 2001 May, 19, 357, 1551-64. Slide 12ɋ-12 Reinforced Antenatal Care Pregnant women at high risk for preterm labour were independently randomized into intervention and control groups at each of five centres (2395 women). Specially trained staff instructed women in the intervention group to recognize early signs of preterm labour and to notify the staff should any sign of preterm labour occur. Women also came in weekly for pelvic examinations after 20 to 24 weeks gestation. Because the intervention had very different and contrary effects on preterm birth rates across these sites, the analysis focused on patient risks and on measures of the process of care as possible explanations for the differences in outcomes. RESULTS: The observed spontaneous preterm birth rates, averaged across all sites, were not lower in the intervention group than in the control groups (16.1% vs. 15.4% for < 37 completed weeks' gestation, 11.9% vs. 10.9% for < 36 completed weeks). There was substantial heterogeneity of program effects between centres (p < 0.01 for homogeneity test statistic). The differences in intervention effects between centres were explainable only in part by patient risk characteristics (p < 0.10 for homogeneity test statistic). The only intermediate measure of the Effective Perinatal Care (EPC) 12C - 10 process of care that tended to differ among sites with positive intervention effects was the rate of hospital admission for preterm labour. Sites with elevated admission rates in the intervention group versus the control group tended to have negative intervention effects on outcomes. CONCLUSION: Because the preterm birth prevention program did not show a reliable benefit and because the reasons for varied outcomes are not understood, the use of the program cannot be recommended for predominantly low-income populations. Depp R et al. Collaborative Group on Preterm Birth Prevention. Multicenter randomized, controlled trial of a preterm birth prevention program. Am J Obstet Gynecol, 1993, 169, 352-366. Slide 12ɋ-13 Cervical Cerclage There were fewer deliveries before 33 weeks in the cerclage group 83 (13%) versus 110 (17%), P = 0.03). This difference reflected deliveries characterised by features of cervical incompetence (painless cervical dilatation and pre-labour rupture of the membranes). There was a corresponding difference in very low birth weight deliveries 63 (10%) versus 86 (13%), P = 0.05). The difference in the overall rate of miscarriage, stillbirth or neonatal death (55 (9%) compared with 68 (11%)) was less marked and was not statistically significant. The use of cervical cerclage was associated with increased medical intervention and a doubling of the risk of puerperal pyrexia. Nevertheless, cervical cerclage should be offered to women at high risk, such as those with a history of three or more pregnancies ending before 37 weeks gestation. One small RCT (35 patients, before 27 weeks of gestation) studied therapeutic cerclage with bed rest versus bed rest alone in women with a short cervix (detected by transvaginal ultrasound). Cervical cerclage was effective for decreasing incidences of preterm deliveries before 34 weeks of gestation (0/19 [0%] v 7/16 [44%] NNT 3), but had no influence on perinatal mortality. Another RCT (113 patients, 16-24 weeks of gestation, short cervix) did not define the influence of cervical cerclage. MRC/RCOG Working party on cervical cerclage. Final report of the Medical Research Council/Royal College of Obstetricians and Gynaecologists multicentre randomised trial of cervical cerclage. Br J Obstet Gynaecol, 1993, 100, 516–523. Althuisius SM et al. Final results of the Cervical Incompetence Prevention Randomised Cerclage Trial (CIPRACT): therapeutic cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol, 2001, 185, 1106 –1112. Module 12C 12C - 11 Slide 12ɋ-14 Bacterial Vaginosis and Preterm Labour Fifteen trials of good quality, involving 5888 women were included in review. Antibiotic therapy was effective at eradicating bacterial vaginosis during pregnancy (Peto odds ratio (OR) 0.17, 95% confidence interval (CI) 0.15 to 0.20; 10 trials, 4357 women). Treatment did not reduce the risk of PTB before 37 weeks (Peto OR 0.91, 95% CI 0.78 to 1.06; 15 trials, 5888 women), or the risk of preterm prelabour rupture of membranes (PPROM) (Peto OR 0.88, 95% CI 0.61 to 1.28; four trials, 2579 women). However, treatment before 20 weeks' gestation may reduce the risk of preterm birth less than 37 weeks (Peto OR 0.63, 95% CI 0.48 to 0.84; five trials, 2387 women). In women with a previous PTB, treatment did not affect the risk of subsequent PTB (Peto OR 0.83, 95% CI 0.59 to 1.17, five trials of 622); however, it may decrease the risk of PPROM (Peto OR 0.14, 95% CI 0.05 to 0.38) and low birthweight (Peto OR 0.31, 95% CI 0.13 to 0.75)(two trials, 114 women). In women with abnormal vaginal flora (intermediate flora or bacterial vaginosis) treatment may reduce the risk of PTB before 37 weeks (Peto OR 0.51, 95% CI 0.32 to 0.81; two trials, 894 women). Clindamycin did not reduce the risk of PTB before 37 weeks (Peto OR 0.80, 95% CI 0.60 to 1.05; six trials, 2406 women). Authors' conclusions Antibiotic treatment can eradicate bacterial vaginosis in pregnancy. This review provides little evidence that screening and treating all pregnant women with asymptomatic bacterial vaginosis will prevent PTB and its consequences. However, there is some suggestion that treatment before 20 weeks' gestation may reduce the risk of PTB. This needs to be further verified by future trials. McDonald HM, Brocklehurst P, Gordon A. Antibiotics for treating bacterial vaginosis in pregnancy. Cochrane Database of Systematic Reviews 2007, Issue 1. Slide 12ɋ-15 Early Diagnostic of Preterm Labour (1) A RCT was conducted in seven European countries, comparing two policies: an attempt to do a cervical examination at every prenatal visit (2803 women) and avoidance of a cervical examination if possible (2799). The median number of cervical examinations was 6 in the experimental group and 1 in the control. There were 6.7% preterm (< 37 weeks) deliveries in the experimental group and 6.4% in the control group (risk ratio 1.05 [95% confidence interval 0.85-1.29]; non- significant). The low birth weight rate was Effective Perinatal Care (EPC) 12C - 12 6.6% in the experimental group and 7.7% in the control (non-significant). Premature rupture of membranes was not significantly more frequent in the experimental group (27.1% vs. 26.5%). The trial did not show statistically significant differences between these two groups in preterm deliveries and PPROM rates. Buekens P et al. Randomised controlled trial of routine cervical examinations in pregnancy. Lancet, 1994, 344, 841-4. Slide 12ɋ-16 Early Diagnostic of Preterm Labour (2) Measurement of the fibronectin level in vaginal discharge after 22 weeks of gestation is a strict prognostic indicator of preterm deliveries. Meta-analysis of 40 trials showed a very high prognostic value of a negative test on foetal fibronectin. Sensitivity of the test in predicting preterm deliveries during 1-2 weeks is 89%, and for preterm deliveries during 3 weeks - 92%. Specificity of the test is 71% for prediction of deliveries during one week and 59% - during 3 weeks. Detecting a short cervix by transvaginal ultrasonograhy has a high prognostic value for preterm deliveries, even in low risk group. If the cervical length < 26 mm, < 22 mm and < 13 mm at 28 weeks of pregnancy, the relative risk of preterm deliveries is 9.57, 13.88 and 24.94, accordingly. If the cervical length is < 15 mm there is a 50% risk to deliver before 32 weeks of gestation. Leitich H, Kaider A. Fetal fibronectin – how useful is it in the prediction of prepterm birth? BJOG, 2003, 10 suppl, 20, 66-70. Hassan SS et al. Patients with an ultrasonographic cervical length < or = 15 mm have nearly a 50% risk of early spontaneous preterm delivery. Am J Obstet Gynecol, 2000, 182, 1458-67. Slide 12ɋ-17 Use of Antibiotics in the Case of Threatened Preterm Labour It has been shown that infection has an important role in the rate of preterm labour. There has been an assumption that prescribing of antibiotics to women with preterm labour could decrease their probability of preterm deliveries. Cochrane Review of 10 RCTs showed statistically reliable prolongation of pregnancy in women with antibiotics (5.4 days), decrease in the rate of maternal infection (OR 0.59, 95% CI 0.36 - 0.97) and necrotizing enterocolitis in newborn (OR 0.33, 95% CI 0.13 - 0.88). Use of antibiotics has no impact on the level of neonatal morbidity (respiratory distress syndrome, neonatal sepsis), but significantly increases the rate of perinatal mortality (OR 3.36, 95% CI 1.21 - 9.32). The authors of the review don’t recommend routine use of antibiotics in women with preterm labour. Module 12C 12C - 13 Kenyon SL et al. Broad-spectrum antibiotics for spontaneous preterm labour: The ORACLE II randomised trial. Lancet, 2001, 357, 989-94. King J, Flenady V. Antibiotics for preterm labour with intact membranes (Cochrane Review). In: The Cochrane Library, 2002, Issue 3. Slide 12ɋ-18 Use of Antibiotics in Case of Preterm Prelabour Rupture of Membranes (PPROM) Systematic review (13 RCTs) shows that prophylactic use of antibiotics (including Erythromycin, Amoxiclav, Benzylpenicillin, Ampicillin, Pyperacillin and Clindamycin) in the case of PROM and preterm pregnancy can lead to statistically significant declines in the rate of maternal postpartum infections (OR 0.85, 95% CI 0.76 - 0.96). The use of antibiotics significantly decreased the number of babies born during 48 hours (OR 0.77, 95% CI 0.72 - 0.83) and 7 days after membrane rupture (OR 0.88, 95% CI 0.84 - 0.92). Use of antibiotics reliably decreased the rate of neonatal infection, including pneumonia (OR 0.67, 95% CI 0.52 - 0.85), positive haemoculture (OR 0.75, 95% CI 0.60 - 0.93) and the number of babies needing oxygentherapy (OR 0.88, 95% CI 0.81 - 0.96). The use of macrolids (Erythromycin) is preferable to a broad spectrum of antibiotics, because, while both have similar effectiveness, macrolids have less complications. For example, the use of Amoxiclav increased the risk of necrotizing enterocolitis by 5 times (OR 4.60, 95% CI 1.98 - 10.72). These data are absolutely sufficient for routine prescription of antibiotics in cases of preterm PROM. Data of later systematic review of 22 trials involving over 6000 women and their babies: The use of antibiotics following PROM is associated with a statistically significant reduction in chorioamnionitis (relative risk (RR) 0.57, 95% confidence interval (CI) 0.37 to 0.86). There was a reduction in the numbers of babies born within 48 hours (RR 0.71, 95% CI 0.58 to 0.87) and seven days of randomisation (RR 0.80, 95% CI 0.71 to 0.90). The following markers of neonatal morbidity were reduced: neonatal infection (RR 0.68, 95% CI 0.53 to 0.87), use of surfactant (RR 0.83, 95% CI 0.72 to 0.96), oxygen therapy (RR 0.88, 95% CI 0.81 to 0.96), and abnormal cerebral ultrasound scan prior to discharge from the hospital (RR 0.82, 95% CI 0.68 to 0.98). Co-amoxiclav was associated with an increased risk of neonatal necrotising enterocolitis (RR 4.60, 95% CI 1.98 to 10.72). Antibiotic administration following PPROM is associated with a delay in delivery and a reduction in major markers of neonatal morbidity. These data support the routine use of antibiotics in PPROM. The choice as to which antibiotic would be preferred is less clear as, by necessity, fewer data are available. Co-amoxiclav should be avoided in women at risk of preterm delivery because of the increased risk of neonatal necrotising enterocolitis. From the available evidence, erythromycin would seem a better choice. Kenyon S, Boulvain M. Antibiotics for preterm premature rupture of membranes. The Cochrane Library, Oxford, Issue 4, 2006 Effective Perinatal Care (EPC) 12C - 14 Slide 12ɋ-19 Is Tocolysis Effective for the Prevention of Preterm Labour? (1) Systematic review of 17 RCTs (2284 women) compared the use of tocolytics in the case of preterm labour versus placebo or the absence of treatment, using betamimetics (most common tocolytics), Magnesia Sulfate, Indometacin and Atosiban (Oxytocin antagonist). In general, the use of tocolytics was associated with a statistically significant decrease in the rate of preterm delivery incidences after 24 hours (OR 0.47, CI 0.29-0.77), after 48 hours (OR 0.57, CI 0.38-0.83) and after 7 days (OR 0.60, CI 0.38-0.95). Nevertheless, this did not lead to a significant decrease in the number of deliveries before 30 weeks of gestation (OR 1.33, CI 0.53-3.33), before 32 weeks of gestation (OR 0.81, CI 0.61-1.07) and before 37 weeks of gestation (OR 0.17, CI 0.02-1.62). The use of tocolytics did not decrease perinatal mortality (OR 1.22; 95% CI 0.84–1.78), severe morbidity of preterm babies RDS (OR 0.82; 95% CI 0.64–1.07), or intraventricular haemorrhages (OR 0.73; 95% CI 0.46–1.15). Gyetvai K et al. Tocolytics for preterm labor: a systematic review. Obstet Gynecol, 1999, 94, 869–77. Slide 12ɋ-20 Is Tocolysis Effective for the Prevention of Preterm Labour? (2) The graph shows the association of tocolytics use with a decrease in the rate of preterm delivery incidences after 24 hours, after 48 hours and after 7 days. Gyetvai K et al. Tocolytics for preterm labor: a systematic review. Obstet Gynecol, 1999, 94, 869–77. Slide 12ɋ-21 Is Tocolysis Effective for the Prevention of Preterm Labour? (3) The use of tocolytics did not decrease perinatal mortality (OR 1.22; 95% CI 0.84–1.78), severe morbidity of preterm babies RDS (OR 0.82; 95% CI 0.64–1.07) or intraventricular haemorrhages (OR 0.73; 95% CI 0.46–1.15). Gyetvai K et al. Tocolytics for preterm labor: a systematic review. Obstet Gynecol, 1999, 94, 869–77. Module 12C 12C - 15 Slide 12ɋ-22 Recommendations on Tocolytics Use Basic recommendations on the use of tocolytics. Royal College of Obstetrics and Gynaecologists (RCOG). Tocolytic drugs for women in preterm labour. RCOG Press, October 2002, Clinical Guideline No. 1(B). Slide 12ɋ-23 Choice of Tocolytics In eleven trials involving 1320 women comparing betamimetics with placebo, betamimetics decreased the number of women in preterm labour giving birth within 48 hours (relative risk (RR) 0.63; 95% confidence interval (CI) 0.53 to 0.75), but there was no decrease in the number of births within seven days. No benefit was demonstrated for betamimetics in terms of perinatal death (RR 0.84; 95% CI 0.46 to 1.55, seven trials, n = 1332) or neonatal death (RR 1.00; 95% CI 0.48 to 2.09, five trials, n = 1174). No significant effect was demonstrated for respiratory distress syndrome (RR 0.87; 95% CI 0.71 to 1.08, eight trials, n = 1239). A few trials reported the following outcomes, with no difference detected: cerebral palsy, infant death and necrotizing enterocolitis. Betamimetics were significantly associated with the following: withdrawal from treatment due to adverse effects; chest pain; dyspnea; tachycardia; palpitation; tremor; headaches; hypokalemia; hyperglycemia; nausea or vomiting; and nasal stuffiness; and fetal tachycardia. Other betamimetics were compared with ritodrine in five trials (n = 948) and hexoprenaline compared with salbutamol in one trial (n = 140). Trials were small, varied and of insufficient quality to delineate any consistent patterns of effect. Analysis of 23 trials which included over 2000 women showed that only nine trials were rated of high quality for the concealment of allocation. In the magnesium sulphate versus control (all studies) no difference was seen for the risk of birth within 48 hours of treatment for women given magnesium sulphate compared with controls when using a random effects model (relative risk (RR) 0.85, 95% confidence interval (CI) 0.58-1.25, 11 trials, 881 women). No benefit was seen for magnesium sulphate on the risk of giving birth preterm (<37 weeks) or very preterm (<34 weeks). The risk of death (fetal and paediatric) was higher for infants exposed to magnesium sulphate (RR 2.82, 95% CI 1.20-6.62, 7 trials, 727 infants). There were only two fetal deaths, both in the magnesium sulphate group of one study. The six other trials reported no fetal deaths. No differences for total paediatric mortality were shown in the six trials with data. No beneficial effect was seen from using magnesium sulphate on the risk of other neonatal morbidity. A non-significant reduction in the risk of cerebral palsy was reported at follow up at 18 months corrected age (RR 0.14, 95% CI 0.01-2.60, 1 trial, 99 children). Effective Perinatal Care (EPC) 12C - 16 Conclusion: Magnesium sulphate is ineffective at delaying birth or preventing preterm birth, and its use is associated with an increased mortality for the infant. Any further trials should be of high quality; large enough to assess serious morbidity and mortality, compare different dose regimens, and provide neurodevelopmental status of the child. S Anotayanonth et al. Betamimetics for inhibiting preterm labour. The Cochrane Database of Systematic Reviews, 2006, Issue 4. CA Crowther et al. Magnesium sulphate for preventing preterm birth in threatened preterm labour. The Cochrane Database of Systematic Reviews, 2006, Issue 4. Illia R et al. Threatened preterm labour. Evaluation of perinatals results in patients treated with betamimetics only and associated with indometacin. The Cochrane Database of Systematic Reviews, 1993 Slide 12ɋ-24 Nifedipine Versus other Tocolytics One systematic review (12 RCTs, 1029 women) compared the use of calcium channel blockers versus other tocolytics (mainly betamimetics) for the treatment of preterm deliveries. Calcium channel blockers decreased the number of women who delivered during 7 days after the beginning of treatment (OR 0.76; 95% CI 0.60 to 0.97) and before 34 weeks of gestation (OR .83; 95% CI 0.69 to 0.99). Compared to other tocolytics, calcium channel blockers decreased the number of women who asked to stop treatment because of side effects (OR 0.14; 95% CI 0.05 to 0.36), RDS incidences (OR 0.63; 95% CI 0.46 to 0.88), necrotizing enterocolitis (OR 0.21; 95% CI 0.05 to 0.96), intraventricular haemorrhages (OR 0.59 95% CI 0.36 to 0.98) and neonatal jaundice (OR 0.73; 95% CI 0.57 to 0.93). A reliable difference was not found for the level of perinatal mortality (10 RCTs, 810 newborns: 13/400 [3%] with the treatment by calcium channel blockers and 7/410 [2%] with the treatment by other tocolytics; (OR 1.65, 95% CI 0.74 to 3.64). The regiment of administration in the largest trial was sublingual 10 mg each 15 minutes during first hour before cessation of contractions, and after 60-160 mg per day of slowly released Nifedipine in dependence of uterus activity. King JF et al. Calcium channel blockers for inhibiting preterm labour. In: The Cochrane Library, 2003, Issue 1. Module 12C 12C - 17 Slide 12ɋ-25 Atosiban Versus Tocolytics Tocolysis was achieved in 92% (12/13) of the women receiving atosiban and 100% (13/13) of those receiving hexoprenaline. Maternal tachycardia developed in 1/13 women, receiving atosiban and 10/13 women hexoprenaline. Hypertension occurred in 1/13 on atosiban and 3/13 women on hexoprenaline. Palpitations were only reported by 10/13 women receiving hexoprenaline. Uterine contractions resumed after 8 minutes (±3) in the atosiban group and 14 minutes (±4) in the hexoprenaline group (P< 0.001). Atosiban and hexoprenaline were similarly effective for stopping uterine contractions. Women receiving atosiban had significantly fewer adverse events than those receiving hexoprenaline. Uterine contractions resumed more promptly in the atosiban group. Considering the low incidence of mild maternal adverse events, atosiban may be an option for acute intrapartum tocolysis for fetal distress. Romero R et al. An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue. Am J Obstet Gyneco,l 2000, 182, 1173–1183. Use of Atosiban (Oxytocin antagonist) was compared with three betamimetics in the big multicentre trial (733 women). No statistically reliable difference between the number of women who did deliver after 48 hours were found among those (317/361 (88%) treated with Atosiban and 330/372 (89%) treated with betamimetics) (OR 0.99; 95% CI 0.94–1.04), and after 7 days (OR 1.03; 95% CI 0.95–1.11). There was no difference in the level of perinatal mortality (OR 0.53; 95% CI 0.20–1.40). But, with the treatment by Atosiban significantly low level of side effects was found: chest pain (1% with Atosiban and 5% with betamimetics), heartbeat (2% and 16%, accordingly), tachycardia (6% and 76%, accordingly), hypotension (3% and 6%, accordingly), breathlessness (0.3% and 7%, accordingly), sickness (12% and 16%, accordingly), vomiting (7% ɢ 22%), and headache (10% and 19%, accordingly). Worldwide Atosiban versus Betamimetics Study Group. Effectiveness and safety of the oxytocin antagonist atosiban versus beta-adrenergic agonists in the treatment of preterm labour. BJOG, 2001, 108, 133–42. Six trials (1695 women) were included in a meta-analysis. Compared with a placebo, atosiban did not reduce the incidence of preterm birth or improve neonatal outcomes. In one trial (583 infants), atosiban was associated with an increase in infant deaths at 12 months of age compared with placebo (relative risk (RR) 6.15; 95% confidence intervals (CI) 1.39 to 27.22). However, this trial randomised significantly more women to atosiban before 26 weeks' gestation. Use of atosiban resulted in lower infant birthweight (weighted mean difference - 138.31 gm; 95% CI -248.76 to -27.86) and more maternal adverse drug reactions (RR 4.02; 95% CI 2.05 to 7.85, 2 trials, 613 women). Compared with betamimetics, atosiban increased the numbers of infants born under 1500 gm (RR 1.96; 95% CI 1.15 to 3.35, 2 trials, 575 infants). Atosiban was associated with fewer maternal drug reactions requiring treatment cessation (RR 0.04; 95% CI 0.02 to 0.11, number needed to treat 6; 95% CI 5 to 7, 4 trials, 1035 women). Effective Perinatal Care (EPC) 12C - 18 Authors' conclusions: This review failed to demonstrate the superiority of atosiban over betamimetics or placebo in terms of tocolytic efficacy or infant outcomes. The finding of an increase in infant deaths in one placebo controlled trial warrants caution. A recent Cochrane review suggests that calcium channel blockers (mainly nifedipine) are associated with better neonatal outcome and fewer maternal side-effects than betamimetics. However, a randomised comparison of nifedipine with placebo is not available. Further well-designed randomised controlled trials of tocolytic therapy are needed. Such trials should incorporate a placebo arm Papatsonis D et al. Oxytocin receptor antagonists for inhibiting preterm labour. The Cochrane Database of Systematic Reviews, 2006, Issue 4. Slide 12ɋ-26 If the Use of Tocolytics Is Effective, Should Use Be Continued? Systematic review of 12 RCTs (1590 women) showed that supportive therapy with tocolytics after the first successful treatment of preterm labour did not decrease repeated preterm labour incidences (OR 0.81 95% CI, 0.64-1.03), preterm deliveries incidences (OR 0.95 (95% CI, 0.77-1.17) and did not improve perinatal outcomes of mortality and morbidity. Thus, results of the trials did not support recommendations on the use of supportive therapy with tocolytics after the first successful treatment of preterm labour. Illia R, Kaunitz AM, Gaudier FL, Delke I. Efficacy of maintenance therapy after acute tocolysis: a meta-analysis. Am J Obstet Gynecol, 1999, 181, 484–90. Some women who have threatened to give birth prematurely subsequently settle. They may then take oral tocolytic maintenance therapy to prevent preterm birth and to prolong gestation. Eleven randomised controlled trials (RCTs) were included in a study investigating tocolytics. No differences were seen for admission to the neonatal intensive care unit when betamimetics were used as compared with the placebo (relative risk (RR) 1.29, 95% confidence interval (CI) 0.64 to 2.60; one RCT of terbutaline with 140 women) or with magnesium (RR 0.80, 95% CI 0.43 to 1.46; one RCT of 137 women). The rate of preterm birth (less than 37 weeks) showed no significant difference in four RCTs, two comparing ritodrine with placebo/no treatment and two comparing terbutaline with placebo/no treatment (RR 1.08, 95% CI 0.88 to 1.32, 384 women). No differences between betamimetics and placebo, no treatment or other tocolytics were seen for perinatal mortality and morbidity outcomes. Some adverse effects such as tachycardia were more frequent in the betamimetics groups than the groups allocated to placebo, no treatment or another type of tocolytic. Authors' conclusions: Available evidence does not support the use of oral betamimetics for maintenance therapy after threatened preterm labour. JM Dodd, CA Crowther, MR Dare, P Middleton. Oral betamimetics for maintenance therapy after threatened preterm labour. The Cochrane Database of Systematic Reviews, 2006, Issue 4. Magnesium maintenance therapy is one of the types of tocolytic therapy used after an episode of threatened preterm labour (and usually an initial dose of tocolytic therapy) in an attempt to prevent the onset of further preterm contractions. Three trials, which recruited 303 women, were included. Two trials were of poor quality and did not include any long-term follow up of infants. Module 12C 12C - 19 No differences in the incidence of preterm birth or perinatal mortality were seen when magnesium maintenance therapy was compared with placebo or no treatment; or alternative therapies (ritodrine or terbutaline). The relative risk (RR) for preterm birth (less than 37 weeks) for magnesium compared with placebo or no treatment was 0.85, 95% confidence interval (CI) 0.47 to 1.51; and 0.98, 95% CI 0.56 to 1.72 for magnesium compared with alternative therapies. The RR for perinatal mortality for magnesium compared with placebo or no treatment, and also compared with alternative treatments, was 5.00, 95% CI 0.25 to 99.16. Women taking magnesium preparations were less likely to report palpitations or tachycardia than women receiving alternative therapies (RR 0.22, 95% CI 0.11 to 0.44) but were much more likely to experience diarrhoea (RR 10.67, 95% CI 3.35 to 33.99). There is not enough evidence to show any difference between magnesium maintenance therapy and either placebo or no treatment, or alternative therapies (ritodrine or terbutaline) in preventing preterm birth after an episode of threatened preterm labour. Crowther CA, Moore V. Magnesium for preventing preterm birth after threatened preterm labour. The Cochrane Database Syst Rev, 2006, Issue 4. Slide 12ɋ-27 No Proven Effectiveness and Not Routinely Recommended Trials (6 RCTs, 122 women) did not show any influence of routine caesarean section versus selective ones in terms of decreasing perinatal mortality and morbidity among very low birth weight: necessity of intubations OR 0.58, 95% CI 0.26 to 1.31. Ahn MO, Cha KY, Phelan JP. The low birth weight infant: is there a preferred route of delivery? Clin Perinatol, 1992, 19, 411-423. Grant A, Penn ZJ, Steer PJ. Elective or selective caesarean delivery of the small baby? A systematic review of the controlled trials. Br J Obstet Gynaecol, 1996, 103, 1197–1200. Slide 12ɋ-28 Conclusions: Effectiveness in Preterm Labour (1) Effectiveness of obstetrical technologies in preterm labour. Effective Perinatal Care (EPC) 12C - 20 Slide 12ɋ-29 Conclusions: Effectiveness in Preterm Labour (2) Effectiveness of obstetrical technologies in preterm labour. Slide 12ɋ-30 Antenatal Use of Corticosteroids (1) RDS is one of the most serious complications of pre-maturity, causing significant immediate and long-term mortality and morbidity and contributing substantially to the cost of neonatal intensive care. The incidence of in developed counties is about 0.5-1.0 % of all births, but in the developing world it may exceed 2-3 % with an extremely high mortality rate. More than 24,000 infants were affected by RDS in United States in 2000. Preterm birth also contributes to neonatal death: x the death rate for infants who were born at <32 weeks of gestation is 5% to 9% x it increases from 25% to 44% for those infants who were born at <28 weeks of gestation Despite repeated randomized trials throughout the 1970s and 1980s and a systematic review of randomized trials in 1987 providing incontrovertible evidence in favour of antenatal corticosteroid therapy, obstetricians all over the world have been slow to adopt this treatment. The causes of this reluctance are unclear. A possible explanation is that the use of antenatal corticosteroids has not been promoted by any pharmaceutical company. Obstetricians may have been influenced by informal reviews that suggested that corticosteroids are effective only in certain small sub-groups of women and babies. The delay between publication of Liggin’s trial (1972) and the general dissemination of this life saving treatment (1990) was one of the driving forces behind the establishment of the Cochrane collaboration. When the database of eligible studies is expanded over a 20-year period to include subsequent randomized clinical trials, the mean risk reduction for both RDS and death becomes greater, and the 95% confidence interval becomes tighter as each study is added. Today antenatal glucocorticoid therapy is a well documented approach for the prevention of RDS, mortality and the other complications of pre- maturity. In 1996 Crowley published updated meta-analysis of 18 clinical trials with the final conclusions (presented at the slide). Crowley P. Prophylactic corticosteroids for preterm birth. (Cochrane Review) In: The Cochrane Library, 2004, Issue 4. Module 12C 12C - 21 Slide 12ɋ-31 Antenatal Use of Corticosteroids (2) Twenty-one studies (3885 women and 4269 infants) are included. Treatment with antenatal corticosteroids does not increase risk to the mother of death, chorioamnionitis or puerperal sepsis. Treatment with antenatal corticosteroids is associated with an overall reduction in neonatal death (relative risk (RR) 0.69, 95% confidence interval (CI) 0.58 to 0.81, 18 studies, 3956 infants), RDS (RR 0.66, 95% CI 0.59 to 0.73, 21 studies, 4038 infants), cerebroventricular haemorrhage (RR 0.54, 95% CI 0.43 to 0.69, 13 studies, 2872 infants), necrotising enterocolitis (RR 0.46, 95% CI 0.29 to 0.74, eight studies, 1675 infants), respiratory support, intensive care admissions (RR 0.80, 95% CI 0.65 to 0.99, two studies, 277 infants) and systemic infections in the first 48 hours of life (RR 0.56, 95% CI 0.38 to 0.85, five studies, 1319 infants). Antenatal corticosteroid use is effective in women with premature rupture of membranes and pregnancy related hypertension syndromes. Evidence from this new review supports the continued use of a single course of antenatal corticosteroids to accelerate fetal lung maturation in women at risk of preterm birth. A single course of antenatal corticosteroids should be considered routine for preterm delivery with few exceptions. Further information is required concerning optimal dose to delivery interval, optimal corticosteroid to use, effects in multiple pregnancies, and to confirm the long-term effects into adulthood. D Roberts, S Dalziel. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. The Cochrane Database of Systematic Reviews, 2006, Issue 4. Slide 12ɋ-32 Antenatal Use of Corticosteroids and Perinatal Outcomes This slide represents the effect of antenatal steroids administration on perinatal outcomes of preterm newborns. Five 95% confidence intervals are completely beyond the “no-effect” vertical line. This means that corticosteroids in comparison with placebo did significantly reduce the risk of neonatal death and odds for RDS, IVH and NEC development. Royal College of Obstetricians and Gynaecologists (RCOG). Antenatal corticosteroids to prevent RDS. RCOG Press, 1996, Guideline No 7. Effective Perinatal Care (EPC) 12C - 22 Slide 12ɋ-33 Corticosteroids in 24-28 Weeks of Gestation Use of corticosteroids in 24 - 28 weeks of gestation has less effect regarding the reduction of RDS, but is associated with increased protection against severe intraventricular haemorrhage (IVH); necrotising enterocolitis for 41% and patent ductus arteriosus (PDA). Trials shows an improved response to subsequent surfactant treatment and reduction in surfactant use [OR – 0,41 (0,18-0,89)]. There is no reliable evidence that antenatal prophylaxis by corticosteroids decreased incidence of bronchopulmonary dysplasia. Crowley P. Prophylactic corticosteroids for preterm birth (Cochrane Review). In: The Cochrane Library, 2004, Issue 4. Slide 12ɋ-34 Use of Corticosteroids and Long-Term Adverse Effects Treatment with antenatal corticosteroids does not increase risk to the mother of death, chorioamnionitis or puerperal sepsis. Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. The Cochrane Database of Systematic Reviews, 2006, Issue 4. Prenatal corticosteroids reduces the risk of RDS (NNT 11; 95% CI 9–16), surfactant use (NNT 9; 95% CI 5–62), intraventricular haemorrhage (NNT 9; 95% CI 6–19) and neonatal mortality (NNT 23; 95% CI 16–42). There are no short-term or long-term adverse effects of a single course of prenatal betamethasone. However, repeated courses of prenatal steroids could be harmful and should be avoided outside of a randomised controlled trial. Henry L. Halliday. Use of steroids in the perinatal period. Paediatric Respiratory Reviews. January 2004, Volume 5, Supplement 1, Pages S321-S327. Studies initiated in the 1970’s followed the development of children treated antenatally with corticosteroids up to the age of 12 years and showed no adverse outcomes in the areas of motor skills, language, cognition, memory, concentration, or scholastic achievement. The possibility of adverse, long-term neurodevelopmental outcomes has been suggested by studies of corticosteroid administration in animals. These studies were conducted using doses approximately 10 times the doses used in human clinical trials. There does not seem to be an increased risk in children of long-term neurodevelopmental impairment, as reflected in any greater prevalence of learning, behavioural, motor, or sensory disturbances. Long-term effects of antenatal corticosteroids on growth and the onset of puberty are not fully known. Module 12C 12C - 23 US National Institute of Health (NIH) Consensus Statement. Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. February 28-March 2, 1994, Volume 12, Number 2. Slide 12ɋ-35 Clinical Indications (1) All women at risk for preterm delivery at 24 to 34 weeks gestational age should receive antenatal corticosteroids for foetal maturation, unless there are contraindications to their administration. Routine use of corticosteroids beyond 34 weeks has no scientific basis. It is clear, however, that some 35- and 36-week neonates can have severe respiratory distress. If clinical situation or amniotic fluid studies suggest marked pulmonary immaturity in these pregnancies, it might be reasonable to offer a course of corticosteroids It must be acknowledged that some foetuses under 24 weeks and some over 34 weeks might benefit from exposure to these drugs when imminent delivery is likely. Most of such younger foetuses probably cannot benefit, because of alveolar structural immaturity. However, with some 22- and 23-week foetuses currently surviving, the question that should be posed is what detriment would occur to the majority (non-survivable) of such foetuses if the accepted 24-week floor were to be slightly lowered. The hope in these cases would be to offer a possible survival advantage to the minority of them who might have the structural maturity to be able to respond. NIH Consensus Statement. Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. February 28-March 2, 1994, Volume 12, Number 2. NIH Consens Statement. Antenatal corticosteroids revisited: repeat courses. August 17-18, 2000, 17(2), 1-10. Slide 12ɋ-36 Clinical Indications (2) Data are insufficient to assess the effectiveness of antenatal corticosteroid use in certain maternal high-risk conditions such as hypertension and diabetes. In the absence of evidence of adverse effects, it may be reasonable to treat these women as one would others with threatened premature delivery. Similarly, in the presence of high-risk fetal conditions, such as multiple gestation, intrauterine growth retardation, and hydrops, it is reasonable to treat these patients as one would others with threatened premature delivery. NIH Consensus Statement. Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. February 28-March 2, 1994, Volume 12, Number 2. Effective Perinatal Care (EPC) 12C - 24 Because there are benefits of treating delivery intervals of less than 24 hours (significant reductions in neonatal mortality, RDS, and intraventricular haemorrhage [IVH]), antenatal corticosteroids should be given unless delivery is imminent. The definition of immediate has not been specified, but because the ability to predict time of delivery is imprecise, there is no contraindication to giving the first dose of steroids. One RCT showed that antenatal use of corticosteroids decreased the risk of RDS (OR 0,5 CI 0,37-0,83), intraventricular haemorrhage (OR 0,35 CI 0,15-0,85), patent arterial duct (OR 0,27 CI 0,08-0,95) and neonatal mortality (OR 0,5 CI 0,28-0,89) in women with severe preeclampsia. Mentioned advantages didn’t followed by increasing of the risk for mother. Amorim MM, Santos LC, Faundes A. Corticosteroid therapy for prevention of respiratory distress syndrome in severe preeclampsia. Am J Obstet Gynecol, 1999 Taking into consideration the high risk of RDS in newborn, antenatal use of corticosteroids can and must be administrated to women with diabetes mellitus with adequate control of glucose. Slide 12ɋ-37 Use of Corticosteroids in Preterm Prelabour Rupture of Membranes Although there is little question that antenatal corticosteroid therapy decreases the risk of RDS, IVH, and neonatal mortality there are several questions that are still incompletely addressed. The first concern is a corticosteroid use in women with preterm premature rupture of membranes (PPROM). In 1994, an obstetric committee opinion from the American College of Obstetricians and Gynaecologists endorsed every recommendation of the 1994 National Institutes of Health (NIH) consensus conference (the first bullet on the slide) except the recommendation to administer corticosteroids for women with PPROM from 24 to 32 weeks’ gestation. There has been conflicting evidence of the efficacy of corticosteroids in preventing RDS in women with PPROM, especially in the very low birth weight group, with concerns of infection further compounding the controversy. Important to notice that some of the mentioned early studies producing the conflicting evidence were conducted at a time when administration of antibiotics for group B streptococcus prophylaxis or for prolongation of the latency period was not routine practice. In her 1995 meta-analysis, Crowley also examined infections reported from four randomized trials that studied antenatal corticosteroid use in women with PPROM. The author found a significant reduction in the incidence of RDS in treated infants (OR = 0,44; 95% CI, 0,32–0,60), whereas no statistically significant effect on neonatal infection was noted; the odds ratio being 0,82, with the 95% confidence interval 0,42 to 1,60. The apparent, one-third reduction in neonatal death rate in this meta-analysis (the second bullet) did not reach statistical significance (RR = 0,68; 95% CI - 0,43–1,07). The investigators further noted that the duration of rupture of membranes did not alter the outcomes. They concluded that available data would indicate that corticosteroid administration is beneficial in the setting of rupture of membranes. Module 12C 12C - 25 Crowley P. Prophylactic corticosteroids for preterm birth (Cochrane Review), The Cochrane Library, 2004, Issue 4. Data from 318 women with rupture of membranes in the Auckland Trial showed that there was a trend toward reduction of the risk of respiratory distress syndrome with corticosteroids but that this trend did not reach statistical significance. There was little effect on the risks of neonatal death, intraventricular hemorrhage, and fetal, neonatal, or maternal infection. Combined data from 15 controlled trials involving >1400 women with rupture of membranes confirmed that corticosteroids reduce the risks of respiratory distress syndrome (relative risk, 0.56; 95% confidence interval, 0.46-0.70), intraventricular hemorrhage (relative risk, 0.47; 95% confidence interval, 0.31-0.70), and necrotizing enterocolitis (relative risk, 0.21; 95% confidence interval, 0.05-0.82). They also may reduce the risk of neonatal death (relative risk, 0.68; 95% confidence interval, 0.43-1.07). They do not appear to increase the risk of infection in either mother (relative risk, 0.86; 95% confidence interval, 0.61-1.20) or baby (relative risk, 1.05; 95% confidence interval, 0.66-1.68). The duration of rupture of membranes does not alter these outcomes. The available data indicate that corticosteroid administration is beneficial in the setting of rupture of membranes. In our opinion further trials to address this question cannot be justified. Harding JE, Pang J, Knight DB, Liggins GC. Do antenatal corticosteroids help in the setting of preterm rupture of membranes? Am J Obstet Gynecol, 2001, 184( 2), 131-139. This study was performed to determine the benefits and risks of multiple courses of corticosteroids in patients with PPROM. The pregnancy and neonatal outcomes of women with singleton pregnancies were retrospectively evaluated, of those who were admitted at 24-32 weeks of gestation due to PPROM. Patients were categorized into 3 groups according to antenatal corticosteoid exposure: (1) a non-user group, (2) a single-course group, and (3) a multiple-course group. Multiple logistic regression analyses showed that multiple courses of corticosteroids were independently associated with clinical chorioamnionitis (odds ratio=13.15, p<0.05) whereas no significant association was found between RDS and multiple-course corticosteroids after adjusting for confounding variables (odds ratio=0.28, p=0.06). CONCLUSION: Multiple courses of antenatal corticosteroid therapy were found to be associated with an increased risk of clinical chorioamnionitis and seemed not to reduce the incidence of RDS and other neonatal morbidities in patients with PPROM. Yang SH, Choi SJ, Roh CR, Kim JH. Multiple courses of antenatal corticosteroid therapy in patients with preterm premature rupture of membranes. J Perinat Med, 2004, 32(1), 42-8. Slide 12ɋ-38 Treatment Regimen for Corticosteroids Treatment of two doses of 12 mg of betamethasone given intramuscularly 24 hours apart or four doses of 6 mg of dexamethasone given intramuscularly 12 hours apart has been shown to be effective. Although these regimens were arbitrarily selected, they have subsequently been shown to deliver concentrations to the fetus that are comparable to physiologic stress levels of cortisol occurring after birth in untreated premature infants who develop RDS. Effective Perinatal Care (EPC) 12C - 26 These regimens resulted in an estimated 75 percent occupancy of available corticosteroid receptors, which should provide a near maximal induction of antenatal corticosteroid receptor- mediated response in fetal target tissues. Higher or more frequent doses do not increase the benefits of antenatal corticosteroid therapy and may increase the likelihood of adverse effects. NIH Consensus Statement. Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. February 28-March 2, 1994, Volume 12, Number 2. Only BTM and DXM, administered as indicated above, were effective in reduction of incidence of RDS and produced no adverse long-term effects for the infants. Two trials studied the use of hydrocortisone gave conflicting results. Trials on the use of methyl- prednisolone were excluded from Crowley’s meta-analysis because this steroid has been shown not to cross the placenta to the foetus. Crowley P. Prophylactic corticosteroids for preterm birth (Cochrane Review). The Cochrane Library, 2004, Issue 4. Slide 12ɋ-39 Betamethasone (BTM) Versus Dexamethasone (DXM) A total of 3600 infants met entry criteria. Compared with no antenatal steroids, there were trends for a reduced risk for PVL associated with dexamethasone and betamethasone but no difference in risk between dexamethasone and betamethasone. Dexamethasone reduced the risk for IVH and severe IVH, compared with no antenatal steroid exposure. Betamethasone reduced the risk for IVH, severe IVH, and neonatal death, compared with no antenatal steroids. Compared with betamethasone, dexamethasone had a statistically significant increased risk for neonatal death. There were trends for greater risks associated with dexamethasone compared with betamethasone for IVH and severe ROP. Betamethasone was associated with a reduced risk for neonatal death, with trends of decreased risk for other adverse neonatal outcomes, compared with dexamethasone. It may be in the best interest of neonates to receive betamethasone rather than dexamethasone when available. Ben H. Lee et al. Adverse Neonatal Outcomes Associated With Antenatal Dexamethasone Versus Antenatal Betamethasone. PEDIATRICS, May 2006, Vol. 117, No. 5, pp. 1503-1510. Questions have recently been raised about the ideal form of corticosteroid to be used in clinical practice. Ultimately, the choice of one preparation over another should be based on a careful analysis of efficacy, potency, cost, convenience, side effects, and safety. The possibility that there may be a real difference between betamethasone and dexamethasone is suggested by several pieces of evidence. So, the answer to the question “Should obstetricians currently using dexamethasone switch to betamethasone?” is “YES”. The Module 12C 12C - 27 recommended preparation is the slowly absorbed mixture of acetate and phosphate salts of betamethasone. Rayburn WF, Christensen HD, Gonzalez CL. A placebo-controlled comparison between betamethasone and dexamethasone for fetal maturation: differences in neurobehavioral development of mice offspring. Am J Obstet Gynecol, 1997, 176, 850–1. Baud O, Foix-Helias L, Kaminski M, et al. Antenatal glucocorticoid treatment and cystic periventricular leukomalacia in very premature infants. N Engl J Med, 1999, 341, 1190–6. Slide 12ɋ-40 Oral Versus Intramuscular Dexamethasone A total of 170 women with 188 fetuses were randomly assigned. The oral and intramuscular groups had similar mean gestational ages at enrolment (29.9 weeks vs 29.2 weeks) and similar median latencies (9.5 vs 10 days). No difference in the frequency of respiratory distress syndrome was found between the oral and intramuscular groups, (34.3% vs 29.8%). Neonatal sepsis (10.1% vs 1.2%, P = .01) and intraventricular haemorrhage (10.1% vs 2.4%, P = .04) were significantly higher in the oral group. There were no statistical differences in the frequencies of necrotizing enterocolitis or neonatal death. A subgroup analysis of 112 patients who were delivered at <34 weeks' gestation revealed no statistical difference in respiratory distress syndrome between the groups; however, oral dexamethasone was associated with a significant increase in sepsis (15.9% vs 1.6%, P = .009) and intraventricular hemorrhage (15.9% vs 3.3%, P = .03). Oral administration increases neonatal morbidity without demonstrable benefit and should not at this time be used clinically for induction of fetal pulmonary maturation. Egerman RS et al. A randomized, controlled trial of oral and intramuscular dexamethasone in the prevention of neonatal respiratory distress syndrome. Am J of Ob Gyn, November 1998, 179, 1120-1123. Slide 12ɋ-41 Single Versus Multiple Courses of Corticosteroid Although the benefit of a single course of antenatal corticosteroids for the prevention of pre-maturity-related complications is indisputable, several concerns limit chronic treatment with these drugs. These concerns have been stimulated by clinical practice of administration of repeated doses of corticosteroids every 7-10 days until 34 wks gestation. This approach became common in nineties and was based on Effective Perinatal Care (EPC) 12C - 28 evidence from early randomised clinical trials suggesting that infants delivered after 7 days of maternal corticosteroid treatment did not have a lower incidence of RDS. Treatment of pregnant mothers with a single course of antenatal corticosteroids significantly reduces neonatal mortality and morbidity. Multiple weekly courses are often given. However, the safety and efficacy of repeated courses of antenatal corticosteroids have not been adequately studied. A retrospective study was performed for 609 mothers and their 713 infants who were treated with 1 to 12 courses of antenatal corticosteroids. Data for 369 singleton preterm infants born at 34 weeks' gestation, 210 multiple gestations, and 134 infants delivered at 35 weeks' gestation were analyzed separately. RESULTS: The incidence of respiratory distress syndrome was 45% for single-course and 35% for multiple-course groups (P =.005; odds ratio, 0.44; 95% confidence interval, 0.25-0.79). The multiple-course group also had significantly less patent ductus arteriosus (20% vs 13%; P =.016). Incidence of death before discharge and other neonatal morbidities were similar. The multiple-course group had a reduction of 0.46 ± 0.19 cm in head circumference at birth (P =.013) when adjusted for gestational age and preeclampsia. The two groups had similar birth weights. Infants born at 35 weeks gestation, multiple- gestation infants, and infants who were born >7 days after the last corticosteroid dose had similar outcomes, regardless of the number of courses they received. Mothers treated with multiple courses compared with a single course had a significantly higher incidence of postpartum endometritis (P =.013), even though they had a lower incidence of prolonged rupture of membranes (24% vs 33%, P =.06) and similar cesarean delivery rates. Exposure to multiple courses of antenatal corticosteroids compared with a single course resulted in a significant reduction in the incidence of respiratory distress syndrome in singleton preterm infants delivered within a week of the last corticosteroid dose. This was associated with a reduction in birth head circumference and an increased incidence of maternal endometritis. Whether the potential benefits of repeated therapy clearly outweigh the risks will ultimately be determined in randomized prospective controlled trials. ABBASI S et al. Effect of single versus multiple courses of antenatal corticosteroids on maternal and neonatal outcome. Am J of Ob Gyn, 2000, vol. 182, #5, pp. 1243-1249. Slide12ɋ-42 Potential Harmful Effects of Repeated Doses of Corticosteroids Maternal pulmonary edema can occur when antenatal corticosteroids are used in combination with tocolytic agents. This complication is more commonly associated with maternal infection, fluid overload, and multiple gestation. Pulmonary edema has not been reported when antenatal corticosteroids are used alone. The risk of maternal infection may be increased when corticosteroids are used in PPROM; however, the degree of this effect, if any, is unclear. Furthermore, there is no evidence that antenatal corticosteroid treatment interferes with the ability to diagnose maternal infection. When corticosteroids are administered to pregnant diabetic women, diabetic control may become more difficult and insulin may have to be adjusted accordingly. Screening for gestational diabetes may similarly be affected. In serious maternal medical conditions that necessitate Module 12C 12C - 29 premature delivery, the delay necessary to demonstrate maximal corticosteroid effects for the fetus may worsen the maternal medical status. A subgroup analysis in the first randomized trial suggested that antenatal corticosteroid administration might predispose to fetal death in hypertensive women. Subsequent trials failed to demonstrate this effect. No long-term maternal adverse effects have been reported. Short-term adverse effects of antenatal corticosteroid administration of greatest concern in the neonate include infection and adrenal suppression. The evidence presented to date shows no increase in infection in treated infants, no clinically important adrenal suppression, and rapid return of adrenal function when antenatal corticosteroids are discontinued. Some animal studies have suggested that antenatal corticosteroid treatment might promote maladaptive responses to hypoxia. Other animal studies have shown that corticosteroids in doses similar to those used in humans antenatally provide protection against hypoxic-ischemic brain injury. More data are needed from human studies in this area of research. NIH Consensus Statement. Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. February 28-March 2, 1994, Volume 12, Number 2. Slide 12ɋ-43 Multiple Courses of Corticosteroid Data from studies on both animals and humans raise questions about the safety of repeat doses of antenatal corticosteroids. For the mother, these include increased maternal infection and suppression of the maternal hypothalamic- pituitary-adrenal axis. Fetal/neonatal effects include decreased somatic and brain growth, adrenal suppression, neonatal sepsis, chronic lung disease, and mortality. No consistent effect on intraventricular hemorrhage was apparent from the available data. Although no increase in the incidence of cerebral palsy was noted, neurodevelopmental follow-up studies suggest an increase in psychomotor delay and behavioral problems. Concern about the effects of repeated corticosteroids on the central nervous system is heightened by the fact that randomized controlled trials of postnatal corticosteroids have found adverse neurologic effects in infants of gestational age similar to those treated in utero. NIH Consensus Statement. Antenatal corticosteroids revisited: repeat courses. August 17-18, 2000, 1-10. The incidence of respiratory distress syndrome was 45% for single-course and 35% for multiple- course groups (P =.005; odds ratio, 0.44; 95% confidence interval, 0.25-0.79). Incidence of death before discharge and other neonatal morbidities were similar. Exposure to multiple courses of antenatal corticosteroids compared with a single course resulted in a significant reduction in the incidence of respiratory distress syndrome in singleton preterm infants delivered within a week of the last corticosteroid dose. This was associated with a reduction in birth head circumference and an increased incidence of maternal endometritis. Whether the potential benefits of repeated therapy clearly outweigh the risks will ultimately be determined in randomized prospective controlled trials. ABBASI S et al. Effect of single versus multiple courses of antenatal corticosteroids on maternal and neonatal outcome. Am J of Ob Gyn, 2000, vol. 182, #5, pp. 1243-1249. Effective Perinatal Care (EPC) 12C - 30 Authors of the biggest trial made a conclusion that weekly regiments should not be prescribed to the pregnant women with high risk of preterm deliveries. Multiple antenatal courses of corticosteroids could decrease the severity of neonatal lung disease. Nevertheless, there is a lack of evidences on the advantages and risks of multiple courses of corticosteroids for the prevention of neonatal lung disease in women of high risk of preterm deliveries. Crowther CA, Harding J. Repeat doses of prenatal corticosteroids for women at risk of preterm birth for preventing neonatal respiratory disease. In: Cochrane Database of Systematic Reviews, 2003, Issue 4. Slide 12ɋ-44 Postnatal Use of Corticosteroids (1) In the nine trials which have reported late outcomes, several adverse neurological effects were found at follow-up examinations of survivors treated with early steroids: developmental delay (not defined), cerebral palsy and abnormal neurological exam. However, major neurosensory disability was not significantly increased, either overall in the four studies where this outcome could be determined, or in the two individual studies where the rate of cerebral palsy and abnormal neurological exam were significantly increased. Moreover, the rate of the combined outcome of death or major neurosensory disability was not significantly increased. Twenty-one randomised controlled trials enrolling a total of 3072 participants were eligible for inclusion in this review. A meta-analysis of these trials demonstrated significant benefits as regards earlier extubation and decreased risks of chronic lung disease (CLD) at both 28 days and 36 weeks, death or CLD at 28 days and 36 weeks, patent ductus arteriosus (PDA) and severe retinopathy of prematurity (ROP). There were no significant differences in the rates of neonatal or subsequent mortality, infection, severe intraventricular haemorrhage (IVH), periventricular leucomalacia (PVL), necrotising enterocolitis (NEC) or pulmonary haemorrhage. Gastrointestinal bleeding and intestinal perforation were important adverse effects and the risks of hyperglycaemia and hypertension were also increased. Halliday HL et al. Early postnatal (<96 hours) corticosteroids for preventing chronic lung disease in preterm infants. The Cochrane Database of Systematic Reviews, 2006, Issue 4. Module 12C 12C - 31 Slide 12ɋ-45 Postnatal Use of Corticosteroids (2) There is extensive data on the adverse effects of unrestricted early postnatal use of corticosteroids to prevent bronchopulmonary dysplasia (BPD), or so called chronic lung disease (CLD). Postnatal steroids do work to decreasing incidences of BPD and even affect mortality. But, for every 11 fewer cases of CLD or death in ventilated preterm infants there are 18 more cases of cerebral palsy and 4.4 more cases of intestinal perforation. This concern is supported by Cochrane;s systematic review presenting a statistically significant increase in incidences of cerebral palsy in preterm infants treated with corticosteroids in the first few days after birth, in comparison with similar newborns who were not given those medications. Halliday HL et al. Effect of corticosteroids given in the first few days after birth in preterm infants on incidence of cerebral palsy in survivors. The Cochrane Database Syst Rev, 2004, Issue 1. Slide 12ɋ-46 Challenges in Caring for the “Small Baby” Small babies have a greater chance to become sick as babies over 2,500g, but it is important to consider that not all small babies are sick. Some of them are just “small’ and for this reason need appropriate care. This care could be provided mainly by the mother/family. Pregnancy, Childbirth, Postpartum and Newborn Care: a guide for essential Practice. WHO, Geneva, 2006 Slide 12ɋ-47 Care for “Small Baby” after Birth (1) Small babies will need resuscitation or assistance in delivery room more often than normal weight infants. Although there has been little recent investigation concerning the role of placental transfusion (or delayed cord clamping) in the prevention of RDS, presumably because of the widespread use of exogenous surfactant, emphasis has been placed on the decreased need Effective Perinatal Care (EPC) 12C - 32 for blood transfusions in preterm infants in whom cord clamping is delayed. The available data suggest that clamping should be delayed a minimum of 30 to 45 seconds in preterm infants (after which time the fetoplacental circulation probably has stopped), which will allow a partial transfusion and may reduce the severity of RDS. In addition, it may minimize the need for blood pressure support, improve iron stores, maintain Hct at a higher level, and decrease the need for subsequent blood transfusions. Pregnancy, Childbirth, Postpartum and Newborn Care: a guide for essential Practice. WHO, Geneva, 2006 Slide 12ɋ-48 Care for “Small Baby” after Birth (2) The warm chain needs to start before birth. The delivery room must be prepared to have an adequate temperature of no less than 25°C. If a birth of premature baby is expected, the adequate temperature needs to be at least 28°C. The delivery room needs to be free of draught. After drying the baby is placed on mother chest in “skin to skin” contact. An important heat loss occurs through the baby’s head (the head constitutes 25% of the body surface). Thus the baby‘s head needs to be covered ideally with a baby hat, but if hat is not available the head could be covered by a piece of linen. Mother and baby need to be covered with a warm blanket. The first breastfeeding will take place when the baby will be ready. Usually this will happen in the first hour of life and will also help baby thermo regulation by helping the baby absorb calories. After “skin to skin” contact, the baby needs to be appropriately dressed, not tightly swaddled, and stay with its mother in the same room (rooming-in). If the baby needs any kind of extra care including resuscitation, heat loss has to be prevented using radiant heater. The newborn must be transported in warm conditions (heated incubator, heated cradles or wrap in warm blanket if not other possibility exist). Thermal Protection of the newborn: a practical guide. WHO, Geneva, 1997 Slide 12ɋ-49 Care for “Small Baby” after Birth (3) Even a healthy baby needs to be monitored carefully during the first two hours after birth. To assess the baby, the staff does not need to interrupt “skin to skin” contact. The breathing rate can be counted by watching the baby’s back. Grunting is easy to listen for and the face colour should be checked. The axillary’s temperature is taken when the baby is in “skin to skin” contact with Module 12C 12C - 33 the mother. Feel baby’s feet every 15 minutes; if cold, check axillary temperature. Check axillary temperature at 30 minutes and 2 hours Assess breathing, colour of the face; hands and feet may stay bluish for 1 to 2 days. Hypoglycemia is a very frequent event in small babies - 15% of preterm infants and 70% of SGA newborns experience hypoglycemia. It occurs due to the limited storage of glycogen often compromised before birth. Pregnancy, Childbirth, Postpartum and Newborn Care: a guide for essential Practice. WHO, Geneva, 2006 Slide 12ɋ-50 Conclusions (1) If the woman is in labour, it is wise to inhibit labour with drugs in order to postpone delivery at least until she arrives at a perinatal centre. The administration of corticosteroids should be commenced before the transfer, unless gestational age has advanced beyond the stage at which respiratory distress syndrome is likely to be a problem. Murray W. Enkin et al. A guide to effective care in pregnancy and childbirth, Oxford University Press, 3rd Edition, 2000 Prophylactic use of antibiotics in the case of PROM and preterm pregnancy can lead to a statistically significant decrease in the rate of maternal postpartum infections. The use of antibiotics significantly decreased the number of babies born during 48 hours and 7 days after membrane rupture. Use of antibiotics reliably decreased the rate of neonatal infection, including pneumonia, positive haemoculture, and the number of babies needing oxygentherapy. The use of macrolids (Erythromycin) is preferable to broad spectrum antibiotics, because, having similar effectiveness, the first is associated with a lower number of complications. For example, use of Amoxiclav increased the risk of necrotizing enterocolitis by 5 times. This evidences is sufficient for the routine prescription of antibiotics in cases of preterm PROM. Kenyon SL et al. Broad-spectrum antibiotics for spontaneous preterm labour: The ORACLE I randomised trial. Lancet, 2001, 357, 979-88. Kenyon S, Boulvain M. Antibiotics for preterm premature rupture of membranes. In: The Cochrane Library, 2002, Issue 2. Effective Perinatal Care (EPC) 12C - 34 Slide 12ɋ-51 Conclusions (2) Finally, antenatal corticosteroids for foetal lung maturation are one of the most studied perinatal interventions. Although the benefits of antenatal corticosteroid therapy may not be uniform throughout this gestational age range, in general the use of such therapy does appear to decrease the risk of RDS, IVH, and neonatal mortality. There are no apparent short or long-term adverse foetal effects with a correctly administered single course of therapy. NIH Consensus Statement. Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. February 28-March 2, 1994, Volume 12, Number 2. Our special concerns are 1) special thermal protection (temperature in the delivery room, availability of radiant wormer, warm linens, clothes, readiness for local transportation); 2) presence of neonatologist (if possible) or the most skilled person at birth; 3) availability of equipment, materials and medications for “extended” resuscitation. Pregnancy, Childbirth, Postpartum and Newborn Care: a guide for essential Practice. WHO, Geneva, 2006 The majority of effective neonatal technologies improving perinatal outcomes in the group of preterm babies are not cost effective. Obstetric technologies have greater effectiveness, are cost effective, and in combination with basic low-price technologies of neonatal care and some organizational measures could significantly improve the results of treatment of low birth weight babies. Module 13ɋ Sudden Infant Death Syndrome (SIDS) Effective Perinatal Care (EPC) 13C - 2 Module 13ǹ Slide 13ɋ-1 Sudden Infant Death Syndrome (SIDS) Module Objectives: x To provide information about Sudden Infant Death Syndrome (SIDS) x To discuss the key known SIDS risk factors x To discuss the key practices to decrease the risk of SIDS Slide 13ɋ-2 Definition In about 60% of deaths from sudden infant death syndrome signs of mild infection were manifest. After thorough autopsy investigation the seriousness of such infections was found insufficient to cause death. Willinger M. Defining the sudden infant death syndrome: deliberations of an expert panel convened by the National Institute of Child Health and Human development, 1991. Slide 13ɋ-3 Causes of Infant Mortality in a Developed Country SIDS is an important cause of infant death in developed countries .In 2000.in New Zealand SIDS was one of the main cause of infant mortality. New Zealand health information service. Principle causes of infant mortality, 2000. 13C - 3 Effective Perinatal Care (EPC) Slide 13ɋ-4 SIDS Facts In spite of decreased frequency in SIDS incidence in developed countries over the past decades, SIDS remains one of main causes of infant deaths during the 1 month to 1 year age range. Exact causes for SIDS are still unknown but many theories exist. However, there are evidence based ,effective, simple recommendations implementation for reducing SIDS incidence by over 50%. The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Policy statement AAP. November 2005. Slide 13ɋ-5 Distribution of SIDS Deaths According to Child’s Age Boys are more vulnerable to SIDS than girls( 60% of SIDS deaths occurs in boys). SIDS seldom occurs during the first month of life. The majority of deaths occur between two and six months of age .After six months, incidence decreases. Annual review Office of the Chief Medical Examiner of province Alberta, Canada. Sudden Infant death syndrome. 1998. Slide 13ɋ-6 SIDS Incidence per 1,000 LB in Selected Countries SIDS incidence in different countries(per thousand).These data reflect differences in SIDS diagnostic criteria in different countries in 2000. In some countries mandatory autopsy are not requested (for example Italy). As a result SIDS diagnoses often rest on clinical symptoms alone and thus rates can vary significantly by country. Global Strategy Task Force Report. Fifth meeting Auckland, New Zealand. 2002. International statistics. 13C - 4 Module 13ǹ Slide 13ɋ-7 SIDS Major Risk Factors SIDS risk factors have been identified through 12 observational studies. The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Policy statement AAP. November 2005. As a result of national campaigns focused on avoidance of major SIDS risk factors including prone sleep position (face down), smoking, overheating, SIDS incidence decreased by 50%. David Creery, Angelo Mikrogianakis. Sudden infant death syndrome. Clinical Evidence, 2006, 15, 1-2. Slide 13ɋ-8 Risk Factors - Prone Sleep Position (1) SIDS risk is especially high when babies are placed on their side to sleep . The chance that infant will turn onto their bellies from a side position is higher than if infants sleep on their backs. There is no evidence of increasing rate of adverse outcomes when non-prone sleeping position were reported. 13 observational studies advise avoiding prone sleeping position. Two studies found no increase in the risk and frequency of aspiration associated with the non-prone position. Three observational studies documented a connection between advice to avoid prone sleeping position and an increase in the incidence of occipital plagiocephaly without synostosis. What are advantages of the BACK TO SLEEP POSITION? Reasons why back to sleep position reduces SIDS risk are not yet well studied. Shall we state a few theories? Babies who sleep on their backs are much easier to wake up. Back to sleep babies sleep less deeply than those who sleep on their bellies. This was noticed by mothers and proven by researchers. Deeper sleep does not mean safer sleep. Babies who sleep on their backs are less likely to overheat.Overheating may impact the baby’s . central nervous system, including the respiratory center. Sleeping on the back keeps the baby’s face uncovered which prevents overheating as well. 13C - 5 Effective Perinatal Care (EPC) Back-sleeping babies get more oxygen than prone-sleeping babies. When babies sleep face down,they breathe the expired air trapped between the face and the mattress which has less oxygen content. Babies sleeping on their backs are less likely to suffocate. Conventional wisdom has been that suffocation is a rare cause of SIDS. It was thought that babies, like adults, are able to raise their heads and to maintain nasal breathing. The often quoted "study" claiming that even tiny infants can lift their heads and clear their noses of obstruction was not really a scientific study; it was more of an observation. New insights cast doubt on the rarity of suffocation. A growing belief among SIDS researchers is that many babies presumably diagnosed as SIDS may have actually died from suffocation on soft surfaces. The side sleeping position is generally considered less safe than the back sleeping position because it is unstable and some infants will roll from the side to a prone position. The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Policy statement AAP. November 2005. Slide 13ɋ-9 Risk Factors - Prone Sleep Position (2) One non-systematic review and 12 observational studies advise to avoid prone sleeping position. Campaigns “Back to Sleep” changed the parent’s habits to place babies for sleeping on prone position and reduced the frequency of SIDS.. Slide 13ɋ-10 England and Wales “Back to Sleep” Campaigns The campaigns were conducted in 1991,and resulted in an immediate decrease of postneonatal mortality to less than 3 per 1000 life birth in 1992 and to 2.5 per 1000 life birth in 1995. The portion of deaths due to SIDS decreased from 1.5 per 1000 to 0.5 per 1000. Sudden infant death syndrome: after the “back to sleep” campaign. BMJ. 1996, 313:180-181. 13C - 6 Module 13ǹ Slide 13ɋ-11 USA “Back to Sleep” Campaign In 1992,the SIDS rate in the U.S.A. was 1.2 deaths per 1000 live births. In 2001 the rate had halved to 0.56 deaths per 1,000 live births and remained the same in 2002. It was suggested that a decline in use of the prone sleeping position from 70% in 1992 (when the "Back to Sleep" campaign was launched nationally) to 11.3% in 2002 may be related to the decline in SIDS. John Caroll, Ellen Siska. SIDS: Counselling Parents to reduce the risk. American Family physician. 1998. Slide 13ɋ-12 Risk Factors – Parental Smoking Mothers should not smoke during pregnancy, because smoking has been identify as a major risk factor in almost every epidemiologic study of SIDS. Smoking in the baby’s environment after birth may be also hazardous, but the risk is less clear. However, numerous reasons in addition to SIDS risk warrant avoiding babies’exposure to second-hand smoke. One non-systematic review and four observational studies found evidence that campaigns to reduce several risk factors for SIDS, including tobacco smoke exposure, were followed by reduced SIDS incidence. One observational study found that smoking was associated with an increased risk of sudden infant death. RCTs investigating the effects of giving advice to reduce infant tobacco smoke exposure would be difficult to conduct, given the extremely large units of randomization required and the high level of pre-existing public awareness regarding the risks associated with tobacco smoke exposure. David Creery, Angelo Mikrogianakis. Sudden infant death syndrome. Clinical Evidence, 2006, 15, 1-2. 13C - 7 Effective Perinatal Care (EPC) Slide 13ɋ-13 Risk Factors – Overheating An infant must be dressed light for sleep to prevent overheating. Parents should be advised to dress a child as they dress, avoiding wrapping and covering the child with many blankets. If the child sweats and his/her hair is moist or if the baby has “heat rash”, the infant may be overheated and can has hyperthermia and/or tachypnoea. David Creery, Angelo Mikrogianakis. Sudden infant death syndrome. Clinical Evidence, 2006, 15, 1-2. Slide 13ɋ-14 Other Risk Factors One observational study talks about the results of a national campaign which recommended avoiding having babies share a bed with mothers, sleeping in prone position, smoking during pregnancy and after birth, and recommending breastfeeding. After this campaign a decrease of SIDS frequency was recorded. The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Policy statement AAP. November 2005. Slide 13ɋ-15 Preterm Birth and SIDS Average post neonatal age of SIDS rises in direct proportion to reduction of gestational age and birth weight. Infants born with over 2,500 g and average post neonatal death age from SIDS of 83 days were compared to infants with average post neonatal SIDS death age of 92 days among infants with birth weight 1,500 g- 2,500 g and to a third group of infant born with a birth weight was 1,500 and less while post neonatal SIDS death age was 127 days. After calculation of adjusted term of gestation for premature babies it was found that SIDS happened approximately in the same post neonatal age both with full-term infants and preterm newborns. Ronald L. Ariagno, Majid Mirmiran, Back to sleep for preterm infants to reduce the risk of SIDS. NeoReviews Vol.4 No.11 November 2003 13C - 8 Module 13ǹ Slide 13ɋ-16 Near Miss for SIDS and ALTE For many years apnea was thought to be predecessor of SIDS and was interpreted as possible near miss for SIDS Home apnoeic monitors were thought to be effective strategy for preventing SIDS. Hhome monitoring did not show significant impact on the overall SIDS rate Alfred Steinschneider: Prolonged apnea and the sudden infant death syndrome: Clinical and laboratory observations.Pediatrics,1972,vol.50,No.4, pp.646-654. The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Policy statement AAP. November 2005. ALTE and near miss SIDS are different .ALTE “ Apparent Life-Threatening Event is a terrifying event and often observer believe the child is dead . The precise risk of SIDS in infants with ALTE is difficult to define.”. But in some cases home monitoring is still recommended such as those who had one or more episodes of severe Apparent Life-Threatening Event (ALTE), siblings of SIDS victims, preterm infants with abnormal apnoea and bradycardia and infants on respiratory support. John Caroll, Ellen Siska. SIDS: Counselling Parents to reduce the risk. American Family physician. 1998. Slide 13ɋ-17 Possible Protective Factors Studies of infant sleep demonstrate that breastfed infants are more easily woken than their formula-fed counterparts. This may explain a possible protective effect against SIDS. However, this has not been shown in all epidemiological studies; other studies show the opposite effect. BREASTFEEDING DECREASES SIDS RISK – EVIDENCE New research confirms that frequency of SIDS is lower among breastfed infants than non breastfed infants.. Research conducted in New Zealand shows that SIDS occurs three time less often in breastfed infants than in those who are not breastfed. The risk of SIDS from not breastfeeding was even higher than the risk associated with mothers who smoke. A large collaborative study of nearly eight hundred SIDS infants performed by the U.S. National Institute of Child Health and Human Development found that SIDS babies were breastfed significantly less often than non- SIDS infants, and if breastfed were weaned earlier. Room sharing: infants should sleep separately from the parents, but nearby. Having infants sleep in the same room as their mother reduces the risk of SIDS. 13C - 9 Effective Perinatal Care (EPC) Although "co-sleepers,"( infant beds that attach to the mother's bed) provide easy access for the mother, safety standards for these devices have not been established. Because bed sharing is more hazardous for the infant, it is recommended than infants brought into bed for nursing or comforting be returned to their own crib or bassinet when the parent is ready to return to sleep.. Having infant share beds with other children, bringing the infant into the parent’s bed when the parent is excessively tired or using medications, and sleeping with an infant on a couch or armchair should also be avoided . Suggest that parent offer a pacifier at nap time or bedtime because pacifier use during sleeps is associated with a reduced risk of SIDS. There is an approximate 1.2- to 2-fold increased risk of otitis media associated with pacifier use but the incidence of otitis media is generally lower in the first year of life, especially the first 6 months when the risk of SIDS is the highest. Many observational studies indicate that pacifier use at any stage of breastfeeding is associated with reduced breastfeeding exclusivity or duration. However, randomized controlled trials indicate that pacifier use after the first month postpartum is not significantly associated with shorter breastfeeding duration. Collins CT, Ryan P, Crowther CA, McPhee AJ, Paterson S, Hiller JE. Effects of bottles, cups, and dummies on breastfeeding on preterm infants: a randomized controlled trial. BMJ, doi: 10.1136/bmj.38131.675914.55. Example :Meta-analysis of studies examining the relationship of a pacifier used during the last sleep in SIDS victims versus controls group. Hauck FR, Omojokun OO, Siadaty MS. Do pacifiers reduce the risk of sudden infant death syndrome? A meta-analysis. Pediatrics. 2005;116:e716. Investigators calculated that 1 SIDS death could be prevented for every 2.733 infants who use a pacifier when placed for sleep. American Association of Pediatricians recommends using a pacifier when putting an infant to sleep during the first year of life and not to reinsert once the infant falls asleep. If the infant refuses the pacifier, he or she should not be forced to take it. The pacifier should not be coated in any sweet solution, and it should be cleaned often and replaced regularly. For breast-fed infants pacifier introduction should be delayed until one month of age. The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Policy statement AAP. November 2005. Slide 13ɋ-18 Campaigns to Reduce Post-Neonatal Mortality From 1988 several developed countries conducted information campaigns mainly advising parents to put babies to sleep on their back As an example in New Zealand .in 1988 the level of post neonatal mortality was 4 per 1,000 life birth and in 1990 after the campaigns it was 2.3 per 1,000. Thus, likely 50% of the cases of post neonatal deaths were due to SIDS. David Creery, Angelo Mikrogianakis. Sudden infant death syndrome. Clinical Evidence, 2006, 15, 1-2. 13C - 10 Module 13ǹ New Zealand health information service. Principle causes of infant mortality, 2000. Slide 13ɋ-19 Informational Materials for SIDS Prevention from the USA and Ukraine Parents counseling: Start counseling by asking the question: In what position does the baby sleep at home? Tell parents to put all babies to sleep on their backs. Explain that this reduces the babies’ SIDS risk and it is the safest position for their babies. Tell them that even though most babies will be just fine, there is a higher risk of SIDS when an infant is placed to sleep on his/her belly or side. If the parents have questions about SIDS and infant sleep position give them a SIDS brochure. Do not agree with parents’ arguments that their baby should sleep on his/her belly “for some time” because he/she is cold or teething or the baby prefers to sleep on his/her belly and etc. www.nichd.nih.gov.sids, USA www.mihp.com.ua, Ukraine Slide 13ɋ-20 Recommendations to Parents on Reducing the Risk of SIDS(1) Healthy newborns are able to protect and are protecting their respiratory tract in the back position. If deglutition and breathing are not disturbed than there is not any risk. (Jeffery, 1996). From the beginning of campaigns to decrease SIDS, an increase in mortality rate due to aspiration syndrome has not been observed. (Fleming 1994). Sleeping in the back position does not increase the apnea or the cyanosis risk (Ponsonby, 1992). Ponsonby AL, Dwyer T, Gibbons LE, et al. Thermal environment and sudden infant death syndrome: case-control study. BMJ 1992;304:277–282. Fleming, P J. 1994. Proceedings of the Fourth Annual SIDS Alliance National Conference, Orlando, FL, November 9-12. Jeffery HE, Henderson-Smart DJ, Hill DA. 1996 Competency-based learning in neonatology. Med Educ 30: 440-4. www.sidscanada.org 2006 13C - 11 Effective Perinatal Care (EPC) Slide 13ɋ-21 Recommendations to Parents on Reducing Risk of SIDS(2) SIDS babies are more likely to have used a pillow or soft mattress and to be found with their nose and mouth completely covered. www.sidscanada.org 2006 Slide 13ɋ-22 Recommendations to parents for reducing risk of SIDS(3) Using information materials, recommend that parents avoid overheating the baby and smoking in the baby’s room. www.sidscanada.org 2006 Slide 13ɋ-23 Steps to prevent SIDS Steps 1-3 have been proven effective. Steps 4-6 steps are complementary The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Policy statement AAP. November 2005. 13C - 12 Module 14ɋ Postpartum Depression, Loss and Tragedies Effective Perinatal Care (EPC) 14C - 2 Module 14C 14C - 3 Slide 14ɋ-1 Postpartum Depression, Loss and Tragedies Learning objectives: x Learn how to provide individual sup- port to the woman with postpartum depression x Learn how to identify early and late psychological reactions of parents to the birth of a sick baby or the death of a baby x Learn how to encourage parents of a sick baby how to be strong enough to provide appropriate care for it x Learn how to provide timely support to parents whose baby has died to help them cope with the grief Slide 14ɋ-2 Physiological Changes during Postnatal Period “Although the days after birth are gener- ally considered a period of intense happi- ness, this period has its dark sides too. During some of these days or even during several weeks many mothers do not feel happy at all; the postpartum period should be considered as a vulnerable time for the development of emotional and psycho- logical disorders.” WHO, 1998, pg 11 WHO, Postpartum Care of the mother and newborn: a practical guide. 1998 Slide 14ɋ-3 Mood Changes after Child- birth Many women (range: 26 to 85 percent) experience the "baby blues," which are characterized by mild depressive symp- toms, tearfulness (often for no discernible reason), anxiety, irritability, mood lability, increased sensitivity and fatigue. The blues typically peak four to five days after delivery, may last hours to days and re- solve by the 10th postnatal day. C. Neill Epperson. Postpartum Major Depression: Detection and Treatment. American Family Physician, 15 April, 1999. Effective Perinatal Care (EPC) 14C - 4 Slide 14ɋ-4 Prevalence of Postpartum Depression and Puerperal Psychosis The World Health Organization (WHO) predicts that depression will be the sec- ond greatest cause of premature death and disability worldwide by the year 2020. The suffering caused by depression is profound yet often underestimated. It can affect every aspect of a person’s being: their feelings, thoughts and functioning. Postnatal depression is particularly impor- tant because it is so common and be- cause it occurs at such a critical time in the lives of the mother, her baby and her family. A large number of studies have assessed the prevalence of postnatal depression. It ranges from 4.5% to 28% of women in the postnatal period. The majority cluster around 10% to 15% with one meta-analysis giving a prevalence of 13% (O’Hara MW. Swain AM., 1996). There is some evidence that, while the overall prevalence of postnatal depression is not significantly dif- ferent from that of depression at other times, there is an increased risk of depression occurring in the early postnatal period (threefold in the first five postnatal weeks). Kendell RE, Chalmers JC, Platz C. Epidemiology of puerperal psychoses. Br J Psychiatry 1987;150:662-73. Murray CJ, Lopez AD. Evidence-based health policy lessons from the Global Burden of Disease Study. Science 1996;274:740-3. O’Hara MW, Swain AM. Rates and risk of postnatal depression – a meta- analysis. Int Rev Psychiatry 1996;8:37-54. Slide 14ɋ-5 Definitions "Postpartum depression" is a clinical term referring to a major depressive episode that is temporally associated with child- birth. When trying to determine if the presence of a symptom is a sign of de- pression or a normal postpartum reaction, the physician should consider the circum- stances. A woman's level of exhaustion and irritability when her infant is two weeks old and nursing frequently may not be normal when her baby is four months old and sleeping soundly through the night. The intensity and degree of a woman's coping response may also indi- cate a pathologic state. Loss of energy and diminished concentration are frequently the result of sleep deprivation. However, for a postpartum woman to have no energy or to have such diffi- culty in concentrating that she frequently loses her train of thought or has considerable difficulty making decisions is not normal. C. Neill Epperson. Postpartum Major Depression: Detection and Treatment. American Family Physician, 15 April, 1999. Module 14C 14C - 5 Postnatal Depression and Puerperal Psychosis, A national clinical guideline. Scottish Intercollegiate Guidelines Network, June 2002. Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ 2001;323:257-60. Slide 14ɋ-6 Risk Factors The evidence suggests that risk factors for postnatal depression are no different to the risk factor for non-postnatal de- pression. In addition to the factors listed on the slide, cohort and case control stud- ies have identified the following as risk factors: parents’ perceptions of their own upbringing, unplanned pregnancy, unem- ployment, not breastfeeding, antenatal parental stress, antenatal thyroid dysfunc- tion, coping style, longer time to concep- tion, depression in fathers, emotional la- bility in maternity blues, low quality social support, having two or more children. O’Hara MW, Swain AM. Rates and risk of postnatal depression – a meta- analysis. Int Rev Psychiatry 1996;8:37-54. Beck CT. A meta-analysis of predictors of postpartum depression. Nurs Res 1996;45:297-303. Wilson LM, Reid AJ, Midmer DK, Biringer A, Carroll JC, Stewart DE. Antenatal psychosocial risk factors associated with adverse postnatal family outcomes. Can Med Assoc J 1996;154:785-99. Forman DN, Videbech P, Hedegaard M, D, Salvig JD, Secher NJ. Postpartum depression: identification of women at risk. Br J Obstet Gy- naecol 2000;107:1210-7. Slice 14ɋ-7 Health Professionals’ Role in Prevention and Management of Postpartum Depression (1) Screening tools have been devised to predict postnatal depression in the ante- natal period. These have been based around known risk factors for postnatal depression, but many have not been properly evaluated to determine sensitiv- ity, specificity and predictive value. There is no evidence to support routine screen- ing in the antenatal period to predict the development of postnatal depression. While no specific screening tools have been devised to identify women at high risk of puerperal psychosis, there is ample evidence that risk factors can be easily identified and are highly predictive. Effective Perinatal Care (EPC) 14C - 6 Postnatal Depression and Puerperal Psychosis, A national clinical guideline. Scottish Intercollegiate Guidelines Network, June 2002. Slice 14ɋ-8 Health Professionals’ Role in Prevention and Management of Postpartum Depression (2) Although many women get depressed right after childbirth, some women don't feel "down" until several weeks or months later. Depression that occurs within 6 months of childbirth may be postpartum depression. C. Neill Epperson. Postpartum Major Depression: Detection and Treatment. American Family Physician, 15 April, 1999. Postnatal Depression and Puerperal Psychosis, A national clinical guideline. Scottish Intercollegiate Guidelines Network, June 2002. Slide 14ɋ-9 Symptoms of Postpartum Depression Studies are evenly divided in reporting postnatal depression as either more or less severe than depression at other times and there is little evidence that the nature of symptoms differs between post- natal and non-postnatal depression. In diagnosing depression in the postnatal period, there is a risk that normal emo- tional changes may be mistaken for de- pression or may mask depressive symp- toms. Usually vegetative symptoms such as loss of libido, appetite loss, sleeping disorder are revealed. Psychosomatic symptoms, for ex- ample, headaches, asthma symptoms, pain in loin, vaginal discharge and pain in a belly, are also reported. Psychological symptoms that are the hardest to recognize may include fix ideas, fear for a baby or for oneself, thoughts of suicide or depersonalization. Obvious aversion to the child may be the extreme reaction. C. Neill Epperson. Postpartum Major Depression: Detection and Treatment. American Family Physician, 15 April, 1999. Module 14C 14C - 7 Slide 14ɋ-10 Questions that Help to Providers to Identify Postpartum De- pression Health care providers need to diagnose postpartum depression as soon as possi- ble to begin providing individual support and treatment for the woman. Slice 14ɋ-11 Principles of Management Untreated postnatal depression may be prolonged and may have a deleterious effect on the relationship between mother and baby and on the child’s cognitive and emotional development. However, the re- sponse to both pharmacological and psy- chosocial interventions is good. Pharmacological and physical manage- ment Hormonal therapies. Hormonal therapies have been the subject of considerable debate, however little reliable evidence is available. No evidence could be identified for the effectiveness of natural progesterone or syn- thetic progestogens in the treatment of postnatal depression. One double blind randomised con- trolled trial indicates that transdermal oestrogen (with cyclical progestogen) is more effective than placebo in moderate to severe postnatal depression. However, concern about side effects, particularly endometrial hyperplasia and thrombosis, may limit its use. Lawrie TA, Herxheimer A, Dalton K. Oestrogens and progestogens for preventing and treating postnatal depression (Cochrane Review). In: The Cochrane Library, Issue 1, 2001. Antidepressants. A randomised controlled trial of the use of antidepressant therapy in postna- tal depression carried out in a community setting in Manchester demonstrated a beneficial effect from fluoxetine combined with at least one session of modified cognitive behavioural therapy (CBT) in women with mild postnatal depression. Evidence from a case control study carried out in the United States suggests that both Selective serotonin reuptake inhibitors (SSRIs) and tri- cyclic antidepressants (TCAs) are effective in postnatal depression. A small case series sug- gests that SSRIs are no less effective in patients with postnatal depression than in other patient groups. Physical therapies and Physical exercise. No evidence was identified relating to the use of electroconvulsive (ECT) therapy in postnatal depression. There is good evidence to support the role of exercise in reducing levels of depression in the general population but little research has been conducted into its role in postnatal depression. Effective Perinatal Care (EPC) 14C - 8 Wisner KL, Gelenberg AJ, Leonard H, Zarin D, Frank E. Pharmacologic treatment of depression during pregnancy. JAMA 1999;282:1264-9. There is limited evidence for the effectiveness of treatment specifically for puerperal psychosis. As the nature of puerperal psychosis is essentially affective, treatments used for affective psy- choses in general are also appropriate for puerperal psychosis. Murray L, Cooper P. The impact of postnatal depression on child development. Int Rev Psychiatry 1996;8:55-63. Appleby L, Warner R, Whitton A, Faragher B. A controlled study of fluoxetine and cognitive-behavioural counselling in the treatment of postnatal depression. BMJ 1997;314:932-6. Postnatal Depression and Puerperal Psychosis, A national clinical guideline. Scottish Intercollegiate Guidelines Network, June 2002. Slide 14ɋ-12 Psychosocial Manage- ment The evidence relating to the role of psy- chosocial interventions in the treatment of postnatal depression focuses mainly on the “talking” therapies, including counsel- ling, psychotherapy, and approaches based upon these techniques. A number of studies have investigated the role of complementary therapies, including mas- sage, infant massage and relaxation therapies in postnatal depression; and a few studies have reviewed the interaction between the depressed mother and her infant. The majority of published studies are descriptive and observational in nature. Methodological weaknesses and small sample sizes limit the conclusions that can be drawn from the few randomized controlled trials identi- fied. Postnatal Depression and Puerperal Psychosis, A national clinical guideline. Scottish Intercollegiate Guidelines Network, June 2002. Slide 14ɋ-13 Counselling in Postpar- tum Depression (1) Counselling is a systematic process which gives individuals an opportunity to ex- plore, discover and clarify ways of living more resourcefully and with a greater sense of wellbeing. It may be concerned with addressing and resolving specific problems, making decisions, coping with crises, working through conflict, or im- proving relationships with others. Holden JM, Sagovsky R, Cox JL. Counselling in a general practice setting: a controlled study of health visitor intervention in treatment of postnatal depression. BMJ 1989;298:223-6. Module 14C 14C - 9 Wickberg B, Hwang CP. Counselling of postnatal depression: controlled study on a population based Swedish sample. J Affect Disord 1996;39:209-16. Department of Health. Treatment choice in psychological therapies and counselling: evidence based clinical practice guideline. The Department: London; 2001. Slide 14ɋ-14 Counselling in Postpar- tum Depression (2) The content of the counselling sessions should be focused on taking care of the child, family relations and woman well- being. Slide 14ɋ-15 Family Focused Interven- tions Several studies focusing on interventions involving the mother and partner and mother with baby have described various benefits. Couple interventions. One study sug- gests that couples involved in an individ- ual or group intervention focused on par- enting and their reactions to it experience a reduction in their depressive symptoms and a benefit to their general health. Interaction focused interventions. The quality of relationship between a mother and her child may be adversely affected by the mother’s depressive condition. Several early in- tervention studies suggest that working with depressed mothers in order to teach different re- sponse patterns to their children can positively affect the mother-infant bond. Infant massage. A small randomised controlled study demonstrated that attending infant mas- sage classes had a significant and positive effect on both mother-infant interaction and depres- sive symptoms in the mother. Field T. Maternal depression: effects on infants and early interventions. Prev Med 1998;27:200-3. Malphurs JE, Field T, Larraine C, Pickens J, Pelaez-Nogueras M, Yando R, et al. Altering withdrawn and intrusive interaction behaviors of depressed mothers. Infant Mental Health J 1996;17:152-60. Effective Perinatal Care (EPC) 14C - 10 Field T, Grizzle N, Scafidi F, Abrams SM, Richardson S. Massage therapy for infants of depressed mothers. Infant Behav Dev 1996;19:107-12 Misri S, Kostaras X, Fox D, Kostaras D. Impact of partner support in the treatment of postpartum depression. Can J Psychiatry 2000;45:554-8. Onzawa K, Glover V, Adams D, Modi N, Kumar RC. Infant massage improves mother-infant interaction for mothers with postnatal depression. J Affect Disord 2001;63:201-7. Slide 14ɋ-16 Parent’s Reaction to a Child Born with Serious Illness or a Congenital Defect When parents have a child born with a serious illness or a congenital defect, they feel a deep sense of grief and loss. In the first phases of reacting to this unex- pected situation, they often experience shock and panic. They can have thoughts or feelings like, “I cannot look after a seri- ously ill child," and may even have feeling of denial, thinking, “It is not my child." This initial phase is then usually followed by the phase of feelings of concession and then resignation when parents begin to cope with the reality of the situation. In some cases, parents are unable to adapt to the situa- tion and remain in continual grief. In this case, the health care worker needs to be in regular contact with the mother and the family to discuss the plan of further care for the child. In addition to feelings of grief and frustration, parents may also find it difficult to see their child’s physical defect. This does not mean that you should separate the mother from the child. It is very important to initiate and maintain close contact between the mother and the family of the child. The support of health care providers can help parents to strengthen their relationship with the child. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Postpartum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. 14ɋ-17 Helping Parents Whose Child Was Born with a Serious Illness or Congenital Defect Parents may find it overwhelming to deal with the potential death of a child born with a serious illness or congenital defect and as a consequence may pull away emotionally and physically from their baby even before the doctors lose hope for its survival. Health care providers need to be very conscious of the lan- guage that they use around parents whose child may be dying because any premature diagnosis hastily stated by a medical worker or even an accidental Module 14C 14C - 11 remark concerning the prognosis of the child could spark this type of reaction in the parents. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Postpartum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Slide 14ɋ-18 Parent’s Reaction to the Death of a Child (1) Often parents whose baby has died may feel intolerance and anger and they may blame the health care workers. This can be due to the fact that the death is unex- pected death and even more intensifies with lack of happened misfortune “scien- tific explanations”. Parents look hard for the cause of death. “Empty hands” is the next usual and hard symptom, which shows when the first stu- por happens. Mother can hear baby’s cry. Lack of normal communication: some evidences show that fathers come to consciousness after grief faster than mothers do. It may provoke problems in their relations. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Postpartum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Slide 14ɋ-19 Parent’s Reaction to the Death of a Child (2) Here the key signs of parents’ reaction are listed. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Post- partum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Effective Perinatal Care (EPC) 14C - 12 Slide 14ɋ-20 Helping the Parents Whose Child Has Died (1) Families who have had a sick child or whose child has died need the assistance of specialists. Health care providers can do a lot to help these families cope with their grief. . A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Pro- ject. 2004. Essential Antenatal, Perinatal and Post- partum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Slide 14ɋ-21 Helping the Parents Whose Child Has Died (2) It is important to facilitate contact between parents and their sick child and to allow the mother to express her milk if she wants. It is also very important to let the parents see their child who has died and to devote time to talk with and listening to these parents. Support is a critical component to helping the family situation deal with their loss and begin the process of returning to normal life. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Postpartum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Module 14C 14C - 13 Slide 14ɋ-22 Helping the Parents Whose Child Has Died (3) The quality of assistance that can be pro- vided to the parents whose child has died is dependent upon the availability of ser- vices in the health care setting. where they have been seeking care. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Post- partum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Slide 14ɋ-23 Death Registration and Funeral Organizing These are the main recommendations to maternity departments on providing assis- tance to families whose children died in in-patient department. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Post- partum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Slide 14ɋ-24 Psychological Help and Support Establishing an atmosphere in the mater- nity where private communication be- tween the patient and provider can take place helps with increasing the patient’s self-esteem and reducing symptoms of post-partum depression and anxiety. A course in antenatal care. Facilitator guide. John Snow, Inc. / Russia WIN Project. 2004. Essential Antenatal, Perinatal and Post- partum Care. WHO, Copenhagen, 2002 WHO postpartum care of the mother and newborn: a practical guide, 1998. Effective Perinatal Care (EPC) 14C - 14 Slide 14ɋ-25 Prevention of Complains and Civil Suits - Top Ten Actions to Avoid To prevent complaints and civil suits health care providers are recommended to use rule “the 10 never”. They are the key recommendations to health care pro- viders in their interaction with women who have postpartum depression and also with women whose children were born with serious illness or malformation or died in maternity department. Final report. John Snow, Inc. / Russia WIN Project. 2004 Slide 14ɋ-26 Postpartum Depression and Loss Summary Module 15ɋ How to Improve Existing Practices: Strategy of Changes Effective Perinatal Care (EPC) 15C - 2 Module 15C Slide 15ɋ-1 How to Improve Existing Practices: Strategy of Changes Purpose of the Module By the end of the training the participants will: x Be able to define quality medical care x Understand basic principles and components of quality medical care x Be able to organize work in a healthcare setting on improvement of medical care quality x Understand the importance of implementing evidence-based practices x Understand main steps in developing clinical guidelines/protocols x Be able to think critically about and use clinical guidelines/protocols x Understand the necessity and main components of a clinical audit x Be able to organize and implement a clinical audit. Slide 15ɋ-2 What Is Quality Medical Care? Doctor Avedis Donabedian is the founder of quality assurance. As the costs of medical care increased considerably in 1980, the users of the medical care system (e.g. patients) and payers (e.g. enterprises and insurance companies) insisted on keeping precise records documenting quality and costs. The model of Total Quality Management (TQM), which includes Continuous Quality Improvement (CQI), was developed by Doctor Edwards Deming and Doctor Joseph Juran. This model has been adopted for quantitative analysis and improvement of medical care quality. The World Health Organization defines quality as ".. appropriate implementation of all activities (according to standards) which are safe, economically acceptable in the present society and influence mortality, disability and inappropriate nutrition" WHO (2000). There is a much simpler definition of quality: “Do it perfectly the first time. Next time do it better” (URC, 2000). In a healthcare setting the task is to hire health care providers who know how to do things correctly and create systems that enable and encourage correct practices. Donabedian A. Exploration in quality assessment and monitoring. Vol.1. The definition of quality and approaches to its assessment, 1980; Vol.2. The criteria and standards of quality, 1982; Vol.3. The methods and findings of quality assessment and monitoring: an illustrated analysis. Ann Arbor: Health Administration Press, 1985 World Health Organisation. The world health report 2000 – Health systems: improving performance. Geneva, WHO, 2000. Joseph M. Juran, A. Blanton Godfrey.Juran's Quality Handbook. Fifth edition, McGraw-Hill,1999 15C - 3 Effective Perinatal Care (EPC) Slide 15ɋ-3 Some Quality Problems Quality problems are reflected in a wide variation in the use of health care services, underuse of some services, overuse of other services, and misuse of services, including an unacceptable level of errors. Variation of services: There continues to be a pattern of wide variation in health care practice, including regional variations and small-area variations. This is a clear indicator that health care practice has not kept pace with the evolving science of health care to ensure evidence-based practice. Underuse of services: Millions of people do not receive necessary care and suffer needless complications that add to costs and reduce productivity. Each year, an estimated 18,000 people in USA die because they do not receive effective interventions. Overuse of services: Each year, millions of Americans receive health care services that are unnecessary, increase costs, and may even endanger their health. Research has shown that this occurs across all populations. For example, an analysis of hysterectomies performed on women in seven health plans found that one in six operations was inappropriate. Misuse of services: Too many people are injured during the course of their treatment, and some die prematurely as a result. Disparities in quality: Although quality problems affect all populations, they may be most marked for embers of ethnic and racial minority populations. Improving Health Care Quality. Fact sheet. Agency for Healthcare Research and Quality. September 2002 Slide 15C-4 Concept of Continuous Quality Improvement of Medical Care There are a number of scientific methods to identify and measure existing changes in quality management of medical care. Selected indicators should be measurable (i.e. accurately measure the parameters they are intending to measure) and trustworthy (i.e. little room for error). After carefully selecting the indicators, data collection and analysis is carried out to analyze the existing situation before implementing activities. When the activities are implemented, data are collected again. Based on the data analysis, a necessary plan of action can be developed to further process changes and improvement. 15C - 4 Module 15C Continuous Quality Improvement (CQI) is an integral part of quality management. CQI builds on and expands previous models of quality provision. CQI is “…the process of quality improvement rather than getting rid of unwanted people.” Its methods are directed towards understanding of complicated processes focused on reaching certain goals or certain activities which lead to final product or result. Tasks related to quality improvement: x Services should be acceptable to patients, providers and society x Services should match the needs x Treatment should be effective and reach desirable results x Treatment should be economical x Means should be equally distributed among those who really need them (to every person – qualitative medical service). Curtis P. McLaughlin, Arnold D. Kaluzny. Continuous Quality Improvement in Health Care. Theory, Implementations and Applications. Third Edition, 2006 Michael A. Counte, Steven Meurer. Issues in the assessment of continuous quality improvement implementation in health care organizations International Journal for Quality in Health Care, 2001, 13:197-207. Vahe A, Kazandjan The effectiveness of CQI in health care: stories from a global perspective. Milwaukee, Wisconsin, ASQC Quality Press, 1997 Slide 15ɋ-5 Definitions Clinical protocols can be seen as more specific than guidelines, defined in greater detail. Protocols provide “a comprehensive set of rigid criteria outlining the management steps for a single clinical condition or aspects of organization.” Clinical practice guidelines and protocols are designed to help practitioners assimilate, evaluate and implement the ever-increasing amount of evidence and opinion on best current practice. Clinical guidelines are intended as neither cookbook nor textbook but, where there is evidence of variation in practice which affects patient outcomes and a strong research base providing evidence of effective practice, guidelines can assist doctors and other health care professionals in making decisions about appropriate and effective care for their patients. Field MJ, Lohr KN (editors). Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical practice guidelines: directions for a new program. Washington DC: National Academy Press; 1990 www.openclinical.org/guidelines.html 15C - 5 Effective Perinatal Care (EPC) Slide 15ɋ-6 Clinical Guideline (Protocol) Guidelines (protocols) can be developed for numerous topics. They can describe strategies for managing different medical states (haemorrhage, pre-eclampsia) or managing various procedures (hysterectomy, transporting children from the operation room to the recovery department). There are many aspects that require the development of clinical guidelines (protocols) development. Defining priorities can be based on: (1) assessment of mortality and morbidity cases that are characteristic for the healthcare setting; (2) effectiveness and availability of evidence for existing procedures; and (3) resources that are accessible for implementation of guidelines (protocols). Advantages for patients: x Improve quality of care x Reduce morbidity and mortality x Standardize treatment x Inform patients about treatments (through brochures, leaflets, video, magazines) x Can serve as a mechanism of payment for services rendered x Shape public opinion. Disadvantages: x Can be developed with mistakes x Frequently treatment and diagnostic options are not evidence-based x Protocol developers may feel responsible x Opinions of leading specialists can prevail x Sometimes the needs of the patients are not prioritized in protocol development. Field MJ, Lohr KN (editors). Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical practice guidelines: directions for a new program. Washington DC: National Academy Press; 1990 Woolf SH, Grol R et al. Clinical guidelines: Potential benefits, limitations, and harms of clinical guidelines. British Medical Journal, 1999, 318:527-530. A guideline developers' handbook. Scottish Intercollegiate Guidelines Network (SIGN), 2004 15C - 6 Module 15C Slide 15ɋ-7 Structure of Guideline (Protocol) Example: Protocol for “Active management of the third stage of labour “ x Goal: Reduction of postpartum haemorrhages x User: Woman in third period of labour x Performer: Midwife x Content: Intramuscular injection of oxytocin (10 Units), cut umbilical cord, controlled cord traction with contra-pressure on uterus, massage of the uterus after delivery the placenta x Place: Birth room x Costs: Cost of oxytocin. Slide 15ɋ-8 Guidelines (Protocols) Implementation There is often a gap between the development of guidelines and their implementation into practice. Implementing guidelines is not simple or straightforward. Identifying barriers to implementation. There are two types of barriers to the implementation of guidelines: those internal to the guideline itself, and the external barriers relating to the clinical environment and particular local circumstances. Potential external barriers to guideline implementation include: x Structural factors (e.g. financial disincentives) x Organisational factors (e.g. inappropriate skill mix, lack of facilities or equipment) x Peer group (e.g. local standards of care not in line with desired practice) x Individual factors (e.g. knowledge attitudes, skills) x Professional-patient interaction (e.g. problems with information processing). Implementation initiatives Implementation of guidelines is a local responsibility and many local initiatives have already been successful in overcoming these barriers to implementation. Team of facilitators with some resources are needed to help local implementation. This is an opportunity to encourage team working and co-operation within primary and secondary care and at the interface between them. Each implementation strategy is effective under certain circumstances, and a multifaceted approach is most likely to achieve change. The approach should be tailored to suit local circumstances taking into account any particular potential barriers. It is important to build in support and incentives and to consider the resources needed for successful implementation. Distribution Guidelines must obviously be made as widely available as possible in order to facilitate implementation (distribution free of charge throughout the region). However, distribution of 15C - 7 Effective Perinatal Care (EPC) printed guidelines alone has been shown to be ineffective in achieving change in practice: guidelines are more likely to be effective if they are disseminated by an active educational intervention, and implemented by patient-specific reminders relating directly to professional activity. For example, distribution of SIGN guidelines in NHS Scotland is organised within each NHS Board by local distribution coordinators, who are often also responsible for facilitating implementation. Monitoring implementation Regular update Every guideline needs to be continually revised to reflect the new evidences. A guideline developers' handbook. Scottish Intercollegiate Guidelines Network (SIGN), 2004 Slide 15ɋ-9 Clinical Audit Over the past years auditing has become an integral part of health systems. Currently, medical and clinical audits are accepted as a part of routine practice in many healthcare settings in Western countries. Clinical audit has been variously defined. The standard definition, and certainly the one endorsed by both NHS and the Healthcare Commission is that “Clinical audit is a quality improvement process that seeks to improve the patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structures, processes and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual team, or service level and further monitoring is used to confirm improvement in healthcare delivery”. Clinical audit is not research. Research is about obtaining new knowledge; about finding out what is best practice. Clinical audit is about quality; about finding out if best practice is being followed. Research is about creating new knowledge about what works and what doesn't. It provides the foundations for national and/or local agreement about the kind of clinical treatment and care we should be providing, i.e. helps to answer the question "what is best practice?" Clinical Audit asks whether we are doing the things we have agreed we should be doing or achieving the outcomes we have agreed we should be achieving, i.e. it answers the question "are we following agreed best practice?" Research and audit projects may look very similar: what differentiates them is purpose. For example, a piece of research may examine outcomes of a particular form of surgery in order to arrive at a conclusion about what represents best practice. A Clinical Audit project might look the same, but the purpose would be to see if a recommended surgical method was producing the expected outcomes. A Practical Handbook for Clinical Audit. Clinical Governance Support Team. National Health Service, March 2005 15C - 8 Module 15C What is Clinical Audit? Clinical Audit Guide. United Bristol Healthcare Trust (UBHT) Clinical Audit Central Office, 2005. Smith R. Audit and research. BMJ 1992, 305:905–6. Slide 15ɋ-10 Audit Spiral Audits can be considered to have five principle stages, in which together form the “audit spiral”: x Topic identification x Standards identification x Data collection to confirm the necessity of standards implementation x Implementation of changes to improve medical care (if needed) x Data collection for secondary identification of practices needing improvement Program of uninterrupted quality improvement: x Set standards which are to be achieved x Identify means for the audit, the assessment of the work and the final indicators of appropriate practices x Determine areas for improvement x Identify areas where the system currently works well. Principles for Best Practice in Clinical Audit. National Health Service, National Institute for Clinical Excellence (NICE), Commission for Health Improvement, Royal College of Nursing, University of Leicester, Radcliffe Medical Press, 2002 Slide 15ɋ-11 Types of Audits Basic clinical audit x Provides several indicators; usually registered in clinical records or computerized information centres. This alone is not an audit, but is often the first stage of the process and can be useful to identify what will be audited. Collection of documentation x Collects required records to be reviewed independently by colleagues. This method is best used to study how records are filed, instead of auditing precise aspects of medical care. Prospective audit x The availability of a control list for a patient to be sure that all procedures have been implemented and that additional protocols are available in the case of abnormal results. Such an audit will be time consuming and has minimal effectiveness. Thematic audit x Auditing a specific topic that is based on concerns at the local level. Additional data collection may be required. 15C - 9 Effective Perinatal Care (EPC) Monitoring of unwanted outcomes x This is a special form of thematic audit which reviews all undesirable outcomes such as maternal mortality, perinatal mortality, or neonatal morbidity. Principles for Best Practice in Clinical Audit. National Health Service, National Institute for Clinical Excellence (NICE), Commission for Health Improvement, Royal College of Nursing, University of Leicester, Radcliffe Medical Press, 2002 Slide 15C-12 Levels of Audit Local level: audit of variations within a department, facility, or professional group National or regional level: audit of regional tendencies or variations within a country International level: audit of differences among countries. Principles for Best Practice in Clinical Audit. National Health Service, National Institute for Clinical Excellence (NICE), Commission for Health Improvement,Royal College of Nursing, University of Leicester, Radcliffe Medical Press, 2002 Slide 15ɋ-13 Audit Principles/Steps Choose an audit topic Projects usually focus on measuring adherence to healthcare processes (investigations, treatments or procedures) that have been shown to produce the best outcomes for patients. As resources for carrying out audit are finite, all topics chosen should be deemed to be important, e.g. based on: x An identified problem (e.g. from complaints or adverse incidents) x High volume, high risk or high cost areas of practice x Published evidence about clinically effective treatment x The availability of clinical guidelines Audits should not be undertaken simply because “it might be interesting to know whether…. Form an audit team Audits are generally described as being either unidisciplinary (e.g. involving only nurses or only doctors) or multidisciplinary (involving more than one discipline or profession). If your audit has implications for professions or disciplines other than your own, whether within or outside the clinical area you work in, make sure they are consulted at the planning stage. If your audit is looking at the patient journey across different care sectors (‘interface’ audit), e.g. 15C - 10 Module 15C referrals into the hospital from primary care, try to include staff representatives from these other organisations in your audit team. Set audit objectives and standards First identify any standards that already exist, in the form of local or national evidence-based guidance. If no guidelines or protocols exist (or the ones that do are several years old), you will need to undertake a literature search, to identify best practice. In either case, it is important to ensure there is consensus agreement with your standards locally before you audit – you will find it hard to improve practice without an agreement about what best practice is! Consider ethics Clinical audit should always be conducted within an ethical framework. If you have any doubts about ethical issues regarding your project, consider getting an ethical opinion, perhaps from the Chairman of the Research Ethics Committee. This would be advisable for instance if you are asking patients sensitive questions as part of a patient survey. Plan and carry out data collection The data you should collect is only what is required to measure practice against the audit standards. Is your audit going to be retrospective (looking back at what has happened in the past) or are you going to collect data prospectively (at the time care is given)? Is data going to be collected using an audit form (proforma) or entered directly onto a computer? Make sure you are clear about exactly who is going to be responsible for doing what and when. Analyze your data Pull your data together in the most meaningful way and compare your results with your standards. How well the standards have have been met? What were the reasons for failure to meet the standard in some cases? Write a report It is important to write up your findings in a report as an official record of the project, ensuring sufficient detail is provided to enable the audit to be repeated in the future. Implement changes and re-audit If an audit shows practice to be in need of improvement, making changes is important: the public has the right to expect that practitioners will provide care that is consistent with recognised good practice. Not all changes will be improvements – don’t make changes for change’s sake. At an appropriate time, repeat the audit (re-audit) to ensure that changes have been implemented and that practice has improved. How to do Clinical Audit – a brief guide. United Bristol Healthcare Trust (UBHT) Clinical Audit Central Office, 2005 Slide 15ɋ-14 Data Collection Data collection in criterion-based audit is generally undertaken to determine the proportion of cases where care is in accordance with the criteria. What data items to collect? Consideration needs to be given to which data items are needed in order to answer the audit question. For example, if undertaking an audit on caesarean section rates, collecting information on the number of caesarean 15C - 11 Effective Perinatal Care (EPC) sections alone will not give sufficient information to measure the caesarean section rate. Data on the number of other births that took place is also required. In general, for audit projects with clear aims, objectives and well-defined review criteria, it is easier to identify those data items that require collection. Definitions need to be clear so that there is no confusion about what is being collected. The definitions will depend upon the review criterion that is being assessed. For example, if collecting data on rupture of membranes, it may need to be specified whether this is spontaneous or artificial. How to collect the data? Sources of data include: x Routinely collected data if available (e.g. birth registers); this enables repeated data collections with the minimum of extra effort x Clinical records x Data collection through direct observation or from questionnaire surveys of staff or patients. Who will collect the data? Thought needs to be given to who will collect the data, as well as the time and resources that will be involved. In small audit projects it may be feasible for the principal investigators to go through clinical notes for data abstraction. However, for larger projects, e.g. a prospective audit on induction of labour practices within a maternity unit, it may be more appropriate for those involved in the care of the woman giving birth (e.g. midwives or obstetricians) to fill in standard data collection sheets. Where available, audit support staff should be involved. Data management Data that are collected on paper forms are usually entered on to electronic databases or spreadsheets such as Microsoft Access®, Epi Info® or Microsoft Excel® for cleaning and analysis. Data analysis Simple statistics are often all that is required. Statistical methods are used to summarise data for presentation in the form of summary statistics (means, medians or percentages) and graphs. Statistical tests are used to find out the likelihood that the data obtained has arisen by chance and how likely it is that a real difference exists between two groups. Data items that have categorical responses (e.g. yes/no or A/B/C/D) can be expressed as percentages. These summary statistics (percentages and means) are useful for describing the process, outcome or service provision that was measured. Principles for Best Practice in Clinical Audit. National Health Service, National Institute for Clinical Excellence (NICE), Commission for Health Improvement, Royal College of Nursing, University of Leicester, Radcliffe Medical Press, 2002. Understanding Audit. Royal College of Obstetricians and Gynecologists (RCOG), Clinical Governance Advice No. 5, October 2003 15C - 12 Module 15C Slide 15ɋ-15 Results (1) Improving the quality of care and reducing medical errors are priority areas for any health care system. A central goal of health care quality improvement is to maintain what is good about the existing health care system while focusing on the areas that need improvement. Clinical guidelines (protocols) are designed to help practitioners assimilate, evaluate and implement the ever- increasing amount of evidence and opinion on best current practice. Slide 15ɋ-16 Results (2) The purpose of the clinical audit is to improve quality of care for patients by analysing current interventions and identifying what interventions need to be added or improved. A clinical audit is the process by which priorities are identified; plans of action are developed; and assessments and implementations of results are carried out. Slide 15ɋ-17 Strategy of Changes 15C - 13 Effective Perinatal Care (EPC) Slide 15ɋ-18 All of Us! The same things are happening in real life. We treat clients in a certain way, and are accustomed to standard sets of manipulations with patients. Even outstanding experts will get stuck in daily routines and do things unthinkingly and automatically, and follow the same patterns from year to year. In this regard, implementation of perinatal technologies in maternities will shatter daily routines and won’t be easy for you and your colleagues. Resistance to new practices is inevitable. Slide 15ɋ-19 Recall a Situation when You Underwent a Significant Change What feelings do people experience when they have to change something? Slide 15ɋ-20 Why Do People Resist Change? Slide lists key reasons that people refuse to change their stereotypes and use innovations in their routine practices. 15C - 14 Module 15C Slide 15ɋ-21 Which Strategies Can Help to Decrease Resistance to Change? Kurt Lewin’s Classic Change Theory: “Unfreezing”: At first systems are disorganized. As a result people start to: x Feel that they need to put things in order; organize work in a new mode x Become morally prepared to change. At this stage it can be helpful to organize a study tour to visit a new model that is well implemented; or a new experimental model can be proposed and tried. It is important to avoid extreme innovations to prevent aggressive resistance. “Moving to a new level”: Conditions that are favourable for change are created. x These conditions are flexible and encourage education and innovation. At this stage it is helpful to provide encouragement and/or incentives for a successful transition to new practices. “Refreezing”: When the main system is stable it is time to reinforce it: x Positive feedback can facilitate the implementation of innovations into routine practices. A continuous process of formal assessment will create true understanding of the usefulness of these changes as well as identify areas needing improvement. Slide 15ɋ-22 Changes are: Why are changes necessary in maternities in particular? 15C - 15 Effective Perinatal Care (EPC) Slide 15ɋ-23 Tool to Facilitate New Practices and Challenges Viewpoints of the following groups should be considered: x Healthcare workers - midwives, obstetricians-gynaecologists, neonatologists and other medical specialists working in the maternities x Institutions - administration, resources, internal rules and regulations x Consumers - women and their families x External conditions - laws, instructions, rules, regulations of Oblast health authorities, etc. and x Public opinion. It is important to consider the most important factors in support of implementing new perinatal technologies (e.g., “ to the best of their knowledge HCP promote breastfeeding”) and the most important obstacles (e.g., “doctors are not accustomed to entrusting midwives“). Slide 15ɋ-24 Action Plan Action plans should include: x Activities required for implementation of effective perinatal technologies x People responsible for each task x Timeframes (when possible) x Resources and support needed for implementation of each task, indicating what is already available and what is needed. An action plan will: x Divide large and complex tasks into small and concrete tasks x Help to comprehend what is possible to achieve with regard to existing material and staff resources x Assign responsibility for certain tasks to specific individuals and define an exact timeframe x Avoid unnecessary and abstract discussions and x Help to understand what additional resources and support are needed so that health administration or authorities can be informed. 15C - 16