Preoperative effects of mifepristone for dilation and evacuation after 19 weeks of gestation: a randomised controlled trial

Shaw, Kate A.; Lerma, Klaira; Shaw, Jonathan G.; Scrivner, Karen; Hugin, Michèle; Hopkins, Frederick W; Blumenthal, Paul D.

doi:10.1111/1471-0528.14900

Cited by 13 publications

(11 citation statements)

References 26 publications

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“…We found that procedures performed at 15–18 weeks' gestation after cervical preparation with mifepristone and misoprostol did not take significantly longer to complete than those performed after overnight preparation with osmotic dilators. This is consistent with findings in a study of surgical abortion after 19 weeks, in which mifepristone in combination with misoprostol had similar operative times compared with preparation with osmotic dilators 16…”

Section: Discussionsupporting

confidence: 90%

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15–18 weeks' gestation: a randomised controlled non-inferiority trial

Paris

Vragovic

Sonalkar

et al. 2019

BMJ Sex Reprod Health

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ObjectiveCervical preparation is recommended prior to second-trimester surgical abortion. Osmotic dilators are an effective means to prepare the cervix, but require an additional procedure and may cause discomfort. We compared cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators.Study designA randomised, controlled, non-inferiority trial was performed to compare cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators in women undergoing surgical abortion between 15 and 18 weeks gestation. The medication group (n=29) received mifepristone 200 mg orally 24 hours prior to uterine evacuation and misoprostol 400 μg buccally 2 hours before the procedure. The dilator group (n=20) underwent osmotic dilator insertion 24 hours prior to the procedure. The primary outcome was total procedure time, from insertion to removal of the speculum. Secondary outcomes included operative time (from intrauterine instrumentation to speculum removal), initial cervical dilation, nausea, pain, ease of procedure, and whether participants would choose the same modality in the future.ResultsFor mean total procedure time, medication preparation (14.0 min, 95% CI 12.0–16.1) was not inferior to dilators (14.3 min, 95% CI 11.7 to 16.8, p<0.001). Mean operative time and ease of procedure were also similar between groups. More women in the medication group than the dilator group would prefer to use the same method in the future (86% vs 30%, p=0.003).ConclusionPrior to surgical abortion at 15–18 weeks, use of mifepristone and misoprostol did not result in longer procedure times than overnight osmotic dilators.Trial registration numberNCT01462.

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Section: Discussionsupporting

confidence: 90%

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15–18 weeks' gestation: a randomised controlled non-inferiority trial

Paris

Vragovic

Sonalkar

et al. 2019

BMJ Sex Reprod Health

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“…Limitations of the study include the few available studies, both of which were challenged with achieving recruitment goals. It is possible that there have been developments in service delivery of second-trimester medical and surgical abortion or in clinical protocols, including management of cervical dilation and pain, that might impact on the acceptability of either method now or in the future 21 22…”

Section: Discussionmentioning

confidence: 99%

Surgical or medical abortion of pregnancies between 13⁺⁰and 23⁺⁶weeks’ gestation? A systematic review and new NICE national guidelines

Schmidt‐Hansen

Lohr

Cameron

et al. 2020

BMJ Sex Reprod Health

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BackgroundAbortion in the second trimester may be performed surgically or medically. The objective of this systematic review was to examine the effectiveness, safety and acceptability/satisfaction of surgical compared with medical abortion of pregnancy between 13+0 and 23+6 weeks’ gestation for a new national guideline.MethodsWe searched Embase, Medline and the Cochrane Library on 4 March 2019. We included randomised controlled trials (RCTs; any size) and non-randomised comparative studies with n≥100 in each arm, published in English from 1985. Risk-of-bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs)used the Mantel-Haenszel method. The quality of the evidence was assessed using GRADE.ResultsTwo RCTs (n=140) were included. ‘Incomplete abortion requiring surgical intervention’ was clinically significantly higher with medical than surgical methods (RR=4.58, 95% CI 1.07 to 19.64). ‘Abortion completed by the intended method’ was statistically, but not clinically, significantly lower after medical than surgical methods, but was marked by high between-study heterogeneity (RR=0.88, 95% CI 0.79 to 0.98). To the extent that ‘haemorrhage requiring transfusion/≥500 mL blood loss’, ‘uterine injury’, ‘cervical injury requiring repair’ and ‘infection reported within 1 month of abortion’ were reported, they did not differ significantly between methods. Depending on measurement method, ‘patient satisfaction/acceptability’ was either clinically significantly higher or comparable after surgical than medical methods. The quality of this evidence was limited by low event rates and attrition bias.ConclusionBased on this evidence and consensus, women should be offered the choice of medical or surgical methods of abortion between 13+0 and 23+6 weeks’ gestation, unless not clinically appropriate.

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“…Adjunctive mifepristone and misoprostol trended towards a shorter procedure time compared to adjunctive misoprostol alone in the most advanced gestational age cohort, but was not statistically significant (10 vs 13 min, p = 0.42). More importantly, elimination of osmotic dilators led to more cervical lacerations, demonstrating their continued importance for safe cervical dilation in late second trimester D&E procedures [24].…”

Section: Methodsmentioning

confidence: 99%

Adjunctive Agents for Cervical Preparation in Second Trimester Surgical Abortion

Ralph

Shulman

2019

Adv Ther

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Late second trimester dilation and evacuation is a challenging subset of surgical abortion. Among the reasons for this is the degree of cervical dilation required to safely extricate fetal parts. Cervical dilation is traditionally achieved by placing multiple sets of osmotic dilators over two or more days prior to the evacuation procedure; however, there is interest in shortening cervical preparation time. The use of adjuvant mifepristone and misoprostol in conjunction with osmotic dilators has been studied for this purpose, and their use demonstrates that adequate cervical dilation can be achieved in less time than with dilators alone. We present a review of the current evidence surrounding adjunctive agents for cervical preparation, and contend that for women presenting for surgical abortion care above 19 weeks gestation, the use of adjunctive mifepristone and/or misoprostol should be strongly considered along with osmotic dilator insertion when cervical preparation in less than 24 h is needed.

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Preoperative effects of mifepristone for dilation and evacuation after 19 weeks of gestation: a randomised controlled trial

Abstract: Mifepristone and misoprostol for cervical preparation prior to D&E has potential to reduce barriers to care.

Cited by 13 publications

References 26 publications

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15–18 weeks' gestation: a randomised controlled non-inferiority trial

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15–18 weeks' gestation: a randomised controlled non-inferiority trial

Surgical or medical abortion of pregnancies between 13⁺⁰and 23⁺⁶weeks’ gestation? A systematic review and new NICE national guidelines

Adjunctive Agents for Cervical Preparation in Second Trimester Surgical Abortion

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Preoperative effects of mifepristone for dilation and evacuation after 19 weeks of gestation: a randomised controlled trial

Abstract: Mifepristone and misoprostol for cervical preparation prior to D&E has potential to reduce barriers to care.

Cited by 13 publications

References 26 publications

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15–18 weeks' gestation: a randomised controlled non-inferiority trial

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15–18 weeks' gestation: a randomised controlled non-inferiority trial

Surgical or medical abortion of pregnancies between 13+0and 23+6weeks’ gestation? A systematic review and new NICE national guidelines

Adjunctive Agents for Cervical Preparation in Second Trimester Surgical Abortion

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Surgical or medical abortion of pregnancies between 13⁺⁰and 23⁺⁶weeks’ gestation? A systematic review and new NICE national guidelines