Labor induction with double balloon catheter, oral misoprostol or both: a randomized controlled trial

Objective To compare cesarean delivery rates and induction outcomes among women undergoing labor induction with a cervical ripening double balloon (DB), oral misoprostol (OM), or a combination of both (DOM). Methods This single-center randomized controlled trial included women with singleton term pregnancies, cephalic presentation, Bishop score ≤ 4, and intact membranes. Participants were randomized to DB for 6 h, oral misoprostol, or combined treatment. The primary outcome was cesarean delivery rate. Secondary outcomes included Bishop score after 6 h, time from induction to delivery, failed induction, and maternal and neonatal outcomes. Due to slow recruitment, the study was stopped early, and complete-case analysis was performed. Results A total of 216 participants were included in the analysis (DB n = 65, OM n = 75, DOM n = 76). Cesarean delivery rates were 20%, 11%, and 20% in the DB, OM, and DOM groups, respectively (p = 0.2). The combined treatment group demonstrated a significantly shorter induction-to-delivery interval (median 14.7 h vs 20.7 in DB [p = 0.006] and 22.9 h in OM [p < 0.001]); higher 6-h Bishop scores (median 6 vs 5 in DB [p = 0.012] and 4 in OM [p < 0.001]);and lower rates of failed induction (2.6% vs 18% in DB [p = 0.010] and 5.4% in OM [p = 0.4]). Maternal and neonatal outcomes were similar across groups. Conclusion Despite limited power this study suggests that combined use of cervical ripening balloon and oral misoprostol shortens induction duration and improves early cervical ripening without increasing cesarean delivery rates. This approach may enhance the efficiency of labor induction. Clinical trial regirstration Date of registration: 03–03–2019. Date of initial participant enrollment, July 1st, 2019. Clinical trial identification number #NCT03866772. URL of the registration site: https://clinicaltrials.gov/study/NCT03866772#study-overview