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Preoperative Effects of Mifepristone for Dilation and Evacuation after 19 Weeks of Gestation
- Published
- September 27th, 2017
- Type
- Publication
- Authors
- Shaw KA, Lerma K, Shaw JG, Scrivner KJ, Hugin M, Hopkins FW, Blumenthal PD
BJOG; 2017 September 27; Vol. 124(13):1973-1981; doi:10.1111/1471-0528.14900
Objective: To evaluate mifepristone as an adjunct to, or replacement for, osmotic dilators for cervical preparation in surgical abortion after 19 weeks of gestation.
Design: Site-stratified, double-blinded randomised controlled trial.
Setiing: Two tertiary care teaching hospitals.
Populations: Women undergoing dilation and evacuation at 19-236/7 weeks of gestation from November 2013 through November 2015.
Methods: Participants 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 measures: Operative time, preoperative cervical dilation and complications.
Results: We 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).
Conclusions: Elimination 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.