Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy A Randomized Controlled Trial

OBJECTIVE:To compare the efficacy of vaginal misoprostol with buccal misoprostol for second-trimester termination of pregnancies.METHODS:In a randomized trial, we compared 400 micrograms vaginal and buccal misoprostol every 3 hours for up to six doses for induction of labor at 13-24 weeks of gestation with a live fetus and intact membranes. Women who had a uterine scar were excluded from the study. The primary outcome of the study was induction-to-abortion interval. Based on a two-tailed of 0.05, we planned to include 65 patients per group to detect a 50% difference in the primary outcome with a power of 80%.RESULTS:From January 2014 to December 2014, 172 women were screened and 130 were randomized: 65 vaginal and 65 buccal misoprostol. Characteristics of patients were similar between groups. Patients administered vaginal misoprostol compared with buccal misoprostol had a shorter induction-to-abortion interval (2517 hours compared with 4029 hours, P=.001) and a higher abortion rate within both 24 hours (41 [63%] compared with 27 [42%] P=.014) and 48 hours (59 [91%] compared with 44 [68%], P=.001). Complete abortion rates were similar in both groups (vaginal 51 [78%] compared with buccal 54 [83%]). The incidence of side effects was similar for both groups. The perceived pain was higher in the buccal group, but the small difference did not appear to be clinically meaningful.CONCLUSION:Vaginal compared with buccal misoprostol administration has a shorter induction-to-abortion interval for second-trimester termination of viable pregnancies. However, both administration routes are equally effective for induction of termination.CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT02048098.LEVEL OF EVIDENCE:I