Abstract
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.
Keywords
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References
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Article info
Publication history
Published online: March 03, 2016
Accepted:
February 29,
2016
Received in revised form:
February 29,
2016
Received:
September 25,
2015
Footnotes
☆Source of Funding: The Society of Family Planning Research Fund.
☆☆This research was presented in part as an oral abstract at the North American Forum on Family Planning, Miami, FL, 2014.
★Conflict of Interest: The authors do not have any conflicts of interest.
★★Clinicaltrials.gov registration: # NCT02412618.
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
