Objective: We evaluated initial cervical dilation with the addition of oral mifepristone to vaginal misoprostol as cervical preparation for same-day. second-trimester dilation and evacuation (D&E). Study design: Women desiring abortion between gestational ages 14. weeks 0. days and 19. weeks 6. days were randomized to 200-mg mifepristone or identical placebo immediately followed by 400-mcg misoprostol vaginally 4-6. h prior to D&E. Primary outcome was cervical dilation assessed by largest Hegar dilator passed without resistance. Secondary outcomes included total procedure time and participant and provider perceptions. We had 90% power to detect a 2-mm change in initial cervical dilation with a mean of 10. mm (SD = 3.0. mm), requiring 48 participants in each arm. Results: Of 100 women enrolled, 96 were randomized and completed the study. Age, race, gestational age (mean 17.4. weeks, SD = 1.3) and parity did not significantly differ. Mean initial Hegar dilation measurements were 11.7 and 10.9. mm in the mifepristone and placebo groups, respectively, with difference of 0.8 [95% CI. =-0.4, 2.0. mm]. We found total procedure times of 11.8 and 13.0. min, respectively (difference of 1.2. min [95% CI. =-2.4, 4.8. min]. Participant and provider perceptions did not differ. All 96 procedures were completed without hemorrhage, cervical laceration or other observed complications. Conclusion: The addition of mifepristone to vaginal misoprostol did not provide a significant increase in cervical dilation compared to misoprostol alone as cervical preparation 4-6. h prior to D&E at 14. weeks through 19. weeks 6. days. Implications: Adding mifepristone for a short interval (4-6. h) did not improve cervical preparation with misoprostol prior to D&E at 14-19. weeks. Future studies should evaluate alternative timing intervals of medications for this purpose.
|Original language||English (US)|
|State||Accepted/In press - Sep 25 2015|
- Dilation and evacuation
ASJC Scopus subject areas
- Reproductive Medicine
- Obstetrics and Gynecology