Ragip A Al1, Omer E Yapca. 1. Department of Obstetrics and Gynecology, Atatürk University Faculty of Medicine, Erzurum, Turkey.
Abstract
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 α 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 65buccal misoprostol. Characteristics of patients were similar between groups. Patients administered vaginal misoprostol compared with buccal misoprostol had a shorter induction-to-abortion interval (25±17 hours compared with 40±29 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.
RCT Entities:
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 α 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 (25±17 hours compared with 40±29 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.