Randomized controlled trial comparing efficacy of a combination regime containing two cervical sensitizers (mifepristone + Foley's catheter) versus single agent mifepristone or Foley's catheter for labor induction in women attempting TOLAC at late third trimester with a dead fetus in utero.

Abstract

To compare efficacy and safety of a new combination regime comprising of two cervical sensitizers used simultaneously with single agents, for labor induction in women attempting TOLAC at ≥34 weeks' gestation with a dead fetus. This was a multiarm randomized controlled trial (RCT) where participants received one of the three regimes-single agent oral Mifepristone 200 mg, intracervical Foley's catheter (16 Fr size, filled with 40 mL normal saline after intracervical instillation), and combination regime consisting of both used simultaneously. Number of women undergoing vaginal birth within 48 h of induction (VB48 ) was the primary outcome compared between groups. VB48 was higher in participants on combination regime in comparison to participants on Foley's catheter (54 vs. 42). Total vaginal births were higher in participants on combination regime compared to both single agents (58 vs. 48 and 44). Duration and dose of oxytocin augmentation was lower in participants on combination regime compared to both single agents. Induction birth interval was short in participants on combination regime compared to those on Foley's catheter. Maternal complications between groups were similar. Combination of cervical sensitizers for labor induction in late third trimester among women with dead fetus attempting TOLAC resulted in higher proportion of vaginal births and might reduce risk of scar dehiscence due to requirement of a lower dose of oxytocin for augmentation.