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

Objective To evaluate mifepristone as an adjunct to, or replacement for, osmotic dilators for cervical preparation in surgical abortion after 19 weeks’ gestation. Design Site-stratified, double-blinded randomised controlled trial. Setting Two tertiary care teaching hospitals. Population Women undergoing dilation and evacuation at 19–236/7 weeks’ 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. Tweetable abstract Mifepristone and misoprostol for cervical preparation prior to D&E has potential to reduce barriers to care.