RESUMO
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. SETTING: Two tertiary care teaching hospitals. POPULATION: 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. TWEETABLE ABSTRACT: Mifepristone and misoprostol for cervical preparation prior to D&E has potential to reduce barriers to care.
