A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy

Objective: To assess differences in outcomes of misoprostol with or without mifepristone for second-trimester abortion. Methods: A randomized, double-blind, placebo-controlled trial of buccal misoprostol following placebo or 200 mg mifepristone was done in Tunisia among women presenting for abortions at 14-21 weeks of pregnancy between August 2009 and December 2011. Women with a live fetus, a closed cervical os, no cervical bleeding, and no contraindications to study drugs were eligible and underwent randomization (block size 10). Participants returned 24 hours later to receive 400 mu g buccal misoprostol every 3 hours until complete fetal and placental expulsion (maximum 10 doses, five per 24-hour period). The primary outcomes were rates of complete uterine evacuation at 48 hours and time to expulsion. Results: A total of 120 women were evenly randomized to treatment. Complete uterine evacuation at 48 hours was recorded in 55 (91.7%) women in the combined group versus 43 (71.7%) in the misoprostol alone group (relative risk 1.28; 95% confidence interval 1.07-153). Mean time to complete abortion was 10.4 +/- 6.6 hours in the group who received mifepristone versus 20.6 +/- 9.7 hours in the misoprostol alone group (P < 0.001). Side effects were similar in both groups. Conclusion: Adding mifepristone before misoprostol can improve the quality of second-trimester abortion care by making the process faster. (C) 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.