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Randomized Controlled Trial Multicenter Study
Preoperative effects of mifepristone for dilation and evacuation after 19 weeks of gestation: a randomised controlled trial.
- K A Shaw, K Lerma, J G Shaw, K J Scrivner, M Hugin, F W Hopkins, and P D Blumenthal.
- Division of Family Planning Services and Research, Department of Obstetrics & Gynecology, Stanford University School of Medicine, Stanford, CA, USA.
- BJOG. 2017 Dec 1; 124 (13): 1973-1981.
ObjectiveTo evaluate mifepristone as an adjunct to, or replacement for, osmotic dilators for cervical preparation in surgical abortion after 19 weeks of gestation.DesignSite-stratified, double-blinded randomised controlled trial.SettingTwo tertiary care teaching hospitals.PopulationWomen undergoing dilation and evacuation at 19-236/7 weeks of gestation from November 2013 through November 2015.MethodsParticipants were randomised to receive (1) mifepristone alone (n = 27), (2) osmotic dilators with mifepristone (n = 27) or (3) osmotic dilators with placebo (n = 21) with all receiving pre-procedure misoprostol.Main Outcome MeasuresOperative time, preoperative cervical dilation and complications.ResultsWe enrolled 75 participants; mean gestation 21 weeks. Pre-procedure cervical dilation was ≥3 cm in 4, 52, and 57% of participants in groups 1, 2, and 3, respectively (P < 0.005). Mifepristone with misoprostol for cervical preparation resulted in longer procedure times compared with osmotic dilators, with median total procedure times of (1) 18.5 (8-52), (2) 12 (7-25), and (3) 13 (6-26) minutes (P ≤ 0.005). Excluding time required for manual dilation, procedure times were similar: median times from dilation complete to evacuation complete were (1) 10.5 (4-23), (2) 8.5 (5-24), and (3) 10 (4-20) minutes (P = 0.10). Complications occurred in seven cases, six with trainees and one with an attending physician (P = 0.03), with difference by study group not reaching statistical significance (P = 0.12).ConclusionsElimination of osmotic dilators has the potential to decrease burden and opportunity cost of cervical preparation. The longer procedure time, related to manual dilation, is offset by decreasing dilator-related preoperative time and discomfort. Provider experience may impact risk when eliminating dilators.Tweetable AbstractMifepristone and misoprostol for cervical preparation prior to D&E has potential to reduce barriers to care.© 2017 Royal College of Obstetricians and Gynaecologists.
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