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A randomized double-blinded comparison of 24-hour interval-mifepristone and buccal misoprostol versus mifepristone and vaginal misoprostol for cervical preparation in second-trimester surgical abortion

Frances Casey, MD, MPH, VCU Medical Center, 2015

Project abstract

Patient preference for medications in place of osmotic dilators as cervical preparation is well known. Twenty-four to 48 hours following mifepristone, vaginal and buccal misoprostol have demonstrated equal efficacy in second-trimester medical abortion but have not been compared as cervical preparation for second-trimester surgical abortion.

This study will randomize participants undergoing a second-trimester surgical abortion between 16 0/7-20 6/7 weeks gestation to 200mg mifepristone followed 20-24 hours later with 400mcg vaginal misoprostol and buccal placebo versus 400mcg buccal misoprostol and vaginal placebo 1-2 hours prior to the procedure. Primary outcome is intraoperative procedure time as measured by time of first instrument in the uterus (dilator if further dilation is required or forceps if no further dilation required) to last instrument out of the uterus. The study uses a superiority design and is powered to detect a 4-minute difference in procedure time from a baseline of 10±5 minutes with 90% power and two-tailed alpha of 0.05 requiring 33 participants in each arm. To account for 10% dropout or disqualification, 72 participants will be recruited. Secondary outcomes include cervical dilation assessed with largest Pratt dilator initially accepted without resistance, patient report of pain (as measured on an 11-point VAS scale), side effects, acceptability, and recommendation to friends (as measured on a 5-point Likert scale), and provider estimation of blood loss, complications, ease of dilation (as measured on an 11-point VAS scale), acceptability, and recommendation to other patients (as measured on a 5-point Likert scale).

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