48 Buccal Versus Vaginal Misoprostol Combined with a Foley Catheter (BEGIN Trial): A Randomized Controlled Trial


      Combining pharmacologic agents with mechanical ripening achieves the shortest labor, yet there is no clear evidence on route of drug administration. The use of buccal misoprostol (miso) has shown greater patient acceptance but remains understudied. Our objective was to evaluate the difference in time to delivery of buccal compared to vaginal miso in combination with a Foley catheter (FC) for labor induction (IOL).

      Study Design

      A randomized clinical trial was conducted from June 2019 through January 2020 comparing identical dosages (25μg) of buccal and vaginal miso in combination with a FC. Randomization was stratified by parity. Labor management was standardized among participants. Women undergoing IOL at ≥37 weeks with a singleton gestation and cervical dilation ≤2cm were included. Our primary outcome was time to delivery. Kruskal-Wallis, Pearson chi-square and Cox survival analyses with intent-to-treat principles were performed.


      215 women (108 Buccal, 107 Vaginal) were randomized. Vaginal drug administration achieved a faster median time to delivery compared to buccal miso, (vaginal miso–FC: 19.7hrs vs. buccal miso–FC: 24.1hrs, p< 0.001). A greater percentage of women in the vaginal administration group delivered within 24hrs (65% versus 49%, p=0.02). There was no difference in the cesarean delivery rate between the two groups (vaginal miso–FC: 17% vs. buccal miso–FC: 21%, p=0.6). Women receiving vaginal miso delivered 1.5 times faster than women who received buccal miso after censoring for Cesarean delivery and adjusting for parity, (Hazard Ratio [HR] 1.5, 95% confidence interval [CI] 1.1-2.0). There were no significant differences in maternal and neonatal outcomes.


      We found that vaginal miso was superior to buccal miso when combined with a FC. Vaginal administration of miso resulted in twice the chance of delivering before a similar dose of buccal miso with no difference in cesarean delivery rates. Therefore, vaginal miso should be the preferred route of drug administration in term IOL.
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