Web annexes: medical management of abortion: evidence summary: 4. timing of post-abortion contraception

1 Web annexes: Medical management of abortion: evidence summary* 4. Timing of post-abortion contraception * This publication forms part of the WHO guideline entitled Medical Management of Abortion. The full guideline and other web annexes are available at: https://www.who.int/reproductivehealth/publications/medical-management-abortion/en/ 2 WHO/RHR/18.37 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this l icence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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In no event shall WHO be liable for damages arising from its use. 3 Contents Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD)............................................................................................... 1 Comparison 1: Immediate (after mifepristone administration) compared with delayed (at or after follow-up visit) initiation of hormonal contraception: implant.......................... 1 Summary of Findings table for Comparison 1 .................................................................................................................................................................................................................... 1 Forest plots for Comparison 1 ............................................................................................................................................................................................................................................. 4 Comparison 2: Immediate (after mifepristone administration) compared with delayed (at or after follow-up visit) initiation of hormonal contraception: depot medroxyprogesterone acetate (DMPA) ................................................................................................................................................................................................................................... 6 Summary of Findings table for Comparison 2 .................................................................................................................................................................................................................... 6 Recommendation 4b: Timing of post-abortion intrauterine device (IUD) placement .......................................................................................................................................................... 1 Comparison: Placement of an IUD at a follow-up visit compared with placement of an IUD at an interval visit after medical abortion regimens ...................................................... 1 Summary of Findings table for Comparison ....................................................................................................................................................................................................................... 1 Forest plots for Comparison ................................................................................................................................................................................................................................................ 4 Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) 1 Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) Comparison 1: Immediate (after mifepristone administration) compared with delayed (at or after follow-up visit) initiation of hormonal contraception: implant Summary of Findings table for Comparison 1 Outcome Anticipated absolute effect * (95% CI) Relative effect (95% CI) No. of participants (studies) Certainty of the evidence (GRADE)1 Comment Risk with delayed initiation of contraceptive implant Risk with immediate initiation of contraceptive implant Efficacy: ongoing pregnancy 8 per 1000 8 per 1000 (1–60) RR 1.02 (0.14–7.16) 476 (1 RCT) 1 ⨁⨁◯◯ LOW a Our confidence in the direct estimate is limited; the true effect may be substantially different from the estimate of the effect Efficacy: any treatment, medical or surgical, to complete abortion b 82 per 1000 98 per 1000 (66–145) RR 1.1980 (0.81–1.77) 1014 (2 RCTs) 1,2 ⨁◯◯◯ VERY LOW c,d Our confidence in the direct estimate is limited; the true effect may be substantially different from the estimate of the effect Efficacy: completed without surgical intervention 950 per 1000 941 per 1000 (912–969) RR 0.99 (0.96–1.02) 1014 (2 RCTs) 1,2 ⨁⨁◯◯ LOW e,f No direct evidence identified Efficacy: contraceptive effectiveness, including unintended pregnancy (failure) 32 per 1000 6 per 1000 (2–20) g RR 0.1831 (0.05–0.62) g 1014 (2 RCTs) 1,2 ⨁⨁◯◯ LOW h Our confidence in the direct estimate is limited; the true effect may be substantially different from the estimate of the effect Safety: serious adverse events; assessed by hospitalization, transfusion, surgery beyond uterine aspiration, death — — — — — No direct evidence identified Side-effects: additional abortion procedures needed due to bleeding (minor) — — — — — No direct evidence identified Bleeding is reported either as duration of bleeding and proportion with heavier bleeding than heavy period or implant removal due to bleeding No study provided detailed information about additional medical or surgical abortion procedures required due to heavy bleeding 1 Grading of Recommendations Assessment, Dev elopment and Ev aluation – more information: http://w w w.gradeworkinggroup.org Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) 2 Outcome Anticipated absolute effect * (95% CI) Relative effect (95% CI) No. of participants (studies) Certainty of the evidence (GRADE)1 Comment Risk with delayed initiation of contraceptive implant Risk with immediate initiation of contraceptive implant Side-effects: contraception discontinued due to bleeding (minor) 42 per 1000 43 per 1000 (19–97) RR 1.03 (0.46–2.29) 538 (1 RCT) 2 ⨁◯◯◯ VERY LOW d,i No direct evidence identified Side-effects: pain/abortion-related pain 479 per 1000 j 521 per 1000 (435–624) j RR 1.09 (0.91–1.30) j 476 (1 RCT) 1 ⨁◯◯◯ VERY LOW d,k Hognert et al.2 measured pain but did not report pain by group Acceptability of immediate contraception before abortion (i.e. not disappointed with assignment; rated as pleased or neutral); assessed by patient report 875 per 1000 979 per 1000 (930–1000) RR 1.1186 (1.06–1.18) 476 (1 RCT) 1 ⨁⨁◯◯ LOW l Acceptability of contraception at 6 months (very satisfied, fairly satisfied, plus neither dissatisfied nor satisfied); assessed by patient report 467 per 1000 598 per 1000 (510–706) RR 1.28 (1.09–1.51) 538 (1 RCT) 2 ⨁◯◯◯ VERY LOW i,m Continuation rates of implant at 6 months 669 per 1000 782 per 1000 (709–863) RR 1.17 (1.06–1.29) 1014 (2 RCTs) 1,2 ⨁◯◯◯ VERY LOW i,n CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio * The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group grades of evidence High certainty: We are very confident that the true effect is close to the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of th e effect. Very low certainty: We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. Explanations a. 95% CI for surgery to complete abortion and any extra surgical or medical treatment to complete abortion include both appreciable benefit and harm. b. Includes surgery for ongoing pregnancy, surgeries for other reasons, and additional medical treatment. No details provided fo r nature or reason of other surgeries. c. Moderate risk for one study and low for the other. d. Downgraded by two: (1) 95% CI crosses 1 and (2) total number of events is < 300. e. 12–14% attrition in one study, low in other. f. 95% CI crosses 1. g. Intention to treat (ITT) not performed. They excluded women who did not have 6 months of follow-up or those who were followed up but were missing pregnancy data. The denominator we use is the number originally randomized (ITT) and our CI assumes both worst case and best case scenarios (e.g. all excluded either did not become pregnant or all became pregnant). Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) 3 h. Concern about outcome assessment: pregnancy at 6 months (contraceptive failure) was defined by the patient not actively reporting being pregnant (self-report) resulting in issues both of accuracy as it relates to pregnancy status early in pregnancy and the need to actively report the pregnancy for it to be coun ted. i. High attrition approximately 30% attrition in immediate and 43% attrition in delayed. j. Measured on scale of 0–10; scores of 8 or higher were considered to be severe. k. Outcome measures not described in protocol; or methods rating scale using 0–10, but categorized as 7 or less, 8 or greater; or missing. l. Concern about high attrition – 28% immediate and 36% delayed at 6 months; no blinding of outcome assessment. m. Event rate is < 300 cases. n. Loss to follow-up between 3–14.4% in immediate and 2.5–20% in delayed groups. References 1. Raymond EG, Weaver MA, Tan YL, Louie KS, Bousiéguez M, Lugo-Hernández EM, et al. Effect of immediate compared with delayed insertion of etonogestrel implants on medical abortion efficacy and repeat pregnancy: a randomized controlled trial. Obstet Gynecol. 2016;127(2):306–12. 2. Hognert H, Kopp Kallner H, Cameron S, Nyrelli C, Jawad I, Heller R, et al. Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion – a randomized controlled equivalence trial. Hum Reprod. 2016;31(11):2484–90. Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) 4 Forest plots for Comparison 1 Analysis 1. Efficacy: additional procedures to complete abortion Analysis 2. Efficacy: completion without surgical intervention Analysis 3. Efficacy: contraceptive effectiveness immediate versus delayed implant Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) 5 Analysis 4. Continuation rates of implant at 6 months Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) 6 Comparison 2: Immediate (after mifepristone administration) compared with delayed (at or after follow-up visit) initiation of hormonal contraception: depot medroxyprogesterone acetate (DMPA) Summary of Findings table for Comparison 2 Outcome Anticipated absolute effect * (95% CI) Relative effect (95% CI) No. of participants (studies) Certainty of the evidence (GRADE) Comment Risk with delayed initiation of DMPA Risk with immediate initiation of DMPA Efficacy: ongoing pregnancy 8 per 1000 36 per 1000 (8–166) RR 4.20 (0.90–19.55) 461 (1 RCT) 1 ⨁⨁◯◯ LOW a Our confidence in the direct estimate is limited; the true effect may be substantially different from the estimate of the effect Efficacy: additional procedures to complete abortion 114 per 1000 116 per 1000 (70–192) RR 1.01 (0.61–1.68) 461 (1 RCT) 1 ⨁⨁◯◯ LOW b Our confidence in the direct estimate is limited; the true effect may be substantially different from the estimate of the effect Efficacy: completed without surgical intervention 51 per 1000 62 per 1000 (29–132) RR 1.22 (0.58–2.59) 461 (1 RCT) 1 ⨁⨁◯◯ LOW b No direct evidence identified Efficacy: contraceptive effectiveness immediate vs delayed (failure) 30 per 1000 c 22 per 1000 (7–69) c RR 0.75 (0.24–2.33) c 461 (1 RCT) 1,c ⨁◯◯◯ VERY LOW b,d,e Our confidence in the direct estimate is limited; the true effect may be substantially different from the estimate of the effect Safety: serious adverse events; assessed by hospitalization, transfusion, surgery beyond uterine aspiration, death — — — — — No direct evidence identified Side-effects: additional abortion procedures due to bleeding (minor) — — — — — No direct evidence identified Bleeding is reported either as duration of bleeding or proportion with heavier bleeding than heavy period No detailed information provided about additional medical or surgical abortion procedures required due to heavy bleeding Side-effects: discontinued contraception due to bleeding (minor) — — — — — No direct evidence identified Side-effects: pain/abortion-related pain 445 per 1000 f 467 per 1000 (382–570) f RR 1.05 (0.86–1.28) f 461 (1 RCT) 1 ⨁◯◯◯ VERY LOW b,g Recommendation 4a: Timing of post-abortion hormonal contraception initiation, except for intrauterine device (IUD) 7 Outcome Anticipated absolute effect * (95% CI) Relative effect (95% CI) No. of participants (studies) Certainty of the evidence (GRADE) Comment Risk with delayed initiation of DMPA Risk with immediate initiation of DMPA Acceptability of immediate contraception before abortion (i.e. not disappointed with assignment; rated as pleased or neutral); assessed by patient report 890 per 1000 982 per 1000 (936–1000) RR 1.10 (1.05–1.16) 461 (1 RCT) 1 ⨁◯◯◯ VERY LOW b,d,h Not defined in methods or protocol Data related to whether participants are not disappointed (i.e. neutral or pleased) with assignment, prior to abortion or contraception CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio * The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). GRADE Working Group grades of evidence High certainty: We are very confident that the true effect is close to the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. Explanations a. 95% CI for surgery to complete abortion and any extra surgical or medical treatment to complete abortion include both appreci able benefit and harm. b. Downgraded by two: (1) 95% CI includes both possible harm and possible benefit; and (2) total number of events is < 300. c. Intention to treat (ITT) not performed. They excluded women who did not have 6 months of follow-up or those who were followed up but were missing pregnancy data. The denominator we use is the number originally randomized (ITT) and our CI assumes both worst case and best case scenarios (e.g. all excluded either did not become pregnant or all became pregnant). d. Outcome measure not described in methods of paper nor in registered protocol. Data presented in abstract indicates satisfaction with group assignment. e. Concern about outcome assessment: pregnancy at 6 months (contraceptive failure) was defined by the patient not actively reporting being pregnant (self-report) resulting in issues both of accuracy as it relates to pregnancy status early in pregnancy and the need to actively report the pregnancy for it to be counted. f. Measured on scale of 0–10; scores of 8 or higher were considered to be severe. g. Outcome measures intent and assessment not reported in registered protocol or methods. h. Outcome measure is satisfaction with group assignment in the study. Unclear whether this is driven by satisfaction with abortion, contraception, study follow-up or other study-related differences in the groups. No description is provided in either of two related studies or their protocols to understand how this was asked. Also patients were significantly different at baseline which was more dramatic than the change in groups over time. This is not accounted for. Reference 1. Raymond EG, Weaver MA, Louie KS, Tan YL, Bousiéguez M, Aranguré-Peraza AG, et al. Effects of depot medroxyprogesterone acetate injection timing on medical abortion efficacy and repeat pregnancy: a randomized controlled trial. Obstet Gynecol. 2016;127(2):306–12. Recommendation 4b: Timing of post-abortion intrauterine device (IUD) placement 1 Recommendation 4b: Timing of post-abortion intrauterine device (IUD) placement Comparison: Placement of an IUD at a follow-up visit compared with placement of an IUD at an interval visit after medical abortion regimens Summary of Findings table for Comparison Outcome Anticipated absolute effect * (95% CI) Relative effect (95% CI) No. of participants (studies) Certainty of the evidence (GRADE) Comment Risk with delayed initiation of an IUD (3–6 weeks after mifepristone) Risk with immediate placement of an IUD (5–7 days after mifepristone) Efficacy: contraceptive effectiveness including unintended pregnancy at 6 months 27 per 1000 3 per 1000 (0–60) RR 0.12 (0.01–2.21) 285 (2 RCTs) 1,2 ⨁⨁◯◯ LOW a,b We are uncertain about the effect of this outcome because the certainty of the evidence is low Efficacy: contraceptive effectiveness including unintended pregnancy at 12 months 120 per 1000 45 per 1000 (18–111) RR 0.37 (0.15–0.92) 267 (1 RCT) 3 ⨁◯◯◯ VERY LOW b,c We are uncertain about the effect of this outcome because the certainty of the evidence is very low Efficacy: need for further intervention (uterine evacuation) post-IUD placement due to retained tissue/bleeding (efficacy of medical abortion) 0 per 1000 0 per 1000 (0–0) RR 1.026 (0.02–51.51) 558 (3 RCTs) 1–5 ⨁⨁◯◯ LOW b,d,e We are uncertain about the effect on this outcome because the certainty of the evidence is low Safety: post-IUD placement infection 77 per 1000 94 per 1000 (46–191) RR 1.21 (0.60–2.47) 333 (2 RCTs) 1,3–5 ⨁⨁◯◯ LOW b,c,f–h We are uncertain about the effect on this outcome because the certainty of the evidence is low Safety: perforation 6 months 0 per 1000 0 per 1000 (0–0) RR 0.91 (0.02–45.46) 250 (2 RCTs) 1,2 ⨁⨁◯◯ LOW a,b We are uncertain about the effect on this outcome because the certainty of the evidence is low Safety: perforation 12 months 0 per 1000 0 per 1000 (0–0) RR 0.87 (0.02–43.55) 217 (1 RCT) 3–5 ⨁◯◯◯ VERY LOW b,c We are uncertain about the effect on this outcome because the certainty of the evidence is very low Safety: expulsion at 6 months 92 per 1000 105 per 1000 (50–224) RR 1.14 (0.54–2.42) 250 (2 RCTs) 1,2 ⨁⨁◯◯ LOW a,b We are uncertain about the effect on this outcome because the certainty of the evidence is low Safety: expulsion at 12 months 38 per 1000 0 per 1000 (0–0) RR 0.48 (0.05–5.16) 217 (1 RCT) 3–5 ⨁◯◯◯ VERY LOW b,c We are uncertain about the effect on this outcome because the certainty of the evidence is very low Recommendation 4b: Timing of post-abortion intrauterine device (IUD) placement 2 Safety: bleeding post-IUD resulting in additional procedures — — — — — Overlaps with need for further intervention post- IUD No events reported Korjamo et al.4,5 reports “bleeding problems” defined as additional contact or an intervention needed but they did not differentiate between the two Safety: death 0 per 1000 0 per 1000 (0–0) RR 1.03 (0.14–7.32) 558 (3 RCTs) 1–5 ⨁◯◯◯ VERY LOW b,c,i We are uncertain about the effect on this outcome because the certainty of the evidence is very low Side-effects: bleeding, contraception discontinued — — — — — Unable to derive GRADE outcome as either not reported or not disaggregated per group Side-effects: pain at IUD insertion (scale 0–10) The mean side-effects – pain at IUD insertion was 0 The mean side-effects – pain at IUD insertion in the intervention group was 0 (0–0) — 90 (1 RCT) 4 ⨁⨁⨁◯ MODERATE j There is probably little or no difference in the pain experienced with IUD insertion when initiation is immediate or delayed following medical abortion for gestations up 63 days Acceptability of/satisfaction with IUD — — — — — No direct evidence identified Continuation rates of IUD at 6 months 608 per 1000 663 per 1000 (559–791) RR 1.09 (0.92–1.30) 285 (2 RCTs) 1,2 ⨁⨁⨁◯ MODERATE a,i There may be little or no difference in the continuation rate of IUD use at 6 months between women who received immediate versus delayed IUD insertion post-medical abortion Continuation rates of IUD at 12 months 391 per 1000 618 per 1000 (481–794) RR 1.58 (1.23–2.03) 267 (1 RCT) 3 ⨁◯◯◯ VERY LOW c,h We are uncertain about the effect on this outcome because the certainty of the evidence is very low CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio * The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). GRADE Working Group grades of evidence High certainty: We are very confident that the true effect is close to the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of e ffect. Explanations a. Risk of bias: downgraded 1: loss to follow-up variable but one study had 24% in delayed placement group. b. Imprecision: downgraded 1 level as studies are relatively small and outcome is an example of a rare event. c. Risk of bias: downgraded 2 levels as loss to follow-up is > 20% in one study. d. Risk of bias: no downgrade: duration of time of follow up is variable across studies (6 versus 12 months); although assuming that need for an intervention either for retained tissue due to the medical abortion following IUD placement would occur within several months postplacement and all studies reported over this time period. Recommendation 4b: Timing of post-abortion intrauterine device (IUD) placement 3 e. Risk of bias: downgraded 2 levels: studies varied in exclusion of subjects who needed uterine evacuation prior to IUD insertion. All studies utilized ultrasound to dete rmine if ongoing pregnancy, missed abortion, or thick endometrium triggering evacuation occurred prior to IUD placement. Thus, interventions were already performed prior to IUD placement in all studies making it unlikely of an intervention being necessary post-IUD placement. f. Risk of bias: downgraded 1 level: one study enrolled women with lower risk of women as routine sexually transmitted infection (STI) screening occurred. g. Risk of bias: no downgrade: duration of time to determine outcome is variable across studies; although assumption would be that likely infection due to post-medical abortion/IUD would occur within several months post-procedure and all studies reported over this time period. h. Inconsistency: no downgrade: only one study accounted for all of the infections reported. i. Risk of bias: no downgrade: duration of time of follow up to determine outcome is variable across studies; although assumption would be that likely a death due to medical abortion and IUD placement would occur within several months post-procedure and all studies reported over this time period. j. Inconsistency: downgraded 1 level: only one study provided pain at insertion data that could be summarized in GRADE format. References 1. Saav I, Stephansson O, Gemzell Danielsson K. Early versus delayed insertion of intrauterine contraception after medical abortion – a randomized controlled trial. PLoS One. 2012;7(11):e48948. 2. Shimoni N, Davis A, Ramos ME, Rosario L, Westhoff C. Timing of copper intrauterine device insertion after medical abortion: a randomized controlled trial. Obstet Gynecol. 2011;118(3):623–8. 3. Korjamo R, Mentula M, Heikinheimo O. Immediate versus delayed initiation of the levonorgestrel-releasing intrauterine system following medical termination of pregnancy – 1 year continuation rates: a randomised controlled trial. BJOG. 2017;124(13):1957–64. 4. Korjamo R, Mentula M, Heikinheimo O. Fast-track vs. delayed insertion of the levonorgestrel-releasing intrauterine system after early medical abortion: a randomized trial. Contraception. 2017;96(5):344–51. 5. Korjamo R, Mentula M, Heikinheimo O. Expulsions and adverse events following immediate and later insertion of a levonorgestre l – releasing intrauterine system after medical termination of late first- and second-trimester pregnancy: a randomised controlled trial. BJOG. 2017;124(13):1965–72. Recommendation 4b: Timing of post-abortion intrauterine device (IUD) placement 4 Forest plots for Comparison Analysis 1. Efficacy: contraceptive effectiveness at 6 months Analysis 2. Safety: infection Recommendation 4b: Timing of post-abortion intrauterine device (IUD) placement 5 Analysis 3. Safety: expulsion at 6 months Analysis 4. Continuation rate at 6 months