A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP)

BACKGROUND: In premature rupture of membranes (PROM), the risk of chorioamnionitis increases with increasing duration of membrane rupture. Decreasing the time from PROM to delivery is associated with lower rates of maternal infection. The American College of Obstetricians and Gynecologists suggests that all women with PROM who do not have a contraindication to vaginal delivery have their labor induced instead of being managed expectantly. Although the use of oxytocin for labor induction has been demonstrated to decrease the time to delivery compared with expectant management, no studies have evaluated the effectiveness of cervical ripening with a Foley bulb to additionally decrease the time to delivery. OBJECTIVE: To determine whether simultaneous use of an intracervical Foley bulb and oxytocin decreases time from induction start to delivery in nulliparous patients with PROM compared with the use of oxytocin alone. STUDY DESIGN: A randomized trial was conducted from August 2014 to February 2016 that compared the use of concurrent Foley bulb/oxytocin vs oxytocin alone in nulliparous patients >= 34 weeks' gestational undergoing labor induction for PROM. Our primary outcome was time from induction to delivery. Secondary outcomes were mode of delivery, tachysystole, chorioamnionitis, postpartum hemorrhage, Apgar scores, and admission to the neonatal intensive care unit. RESULTS: A total of 128 women were randomized. Baseline characteristics were similar between groups. We found no difference in induction-to-delivery time between women induced with concurrent Foley bulb/oxytocin vs oxytocin alone (median time 13.0 hours [inter-quartile 10.7, 16.1] compared with 10.8 hours [interquartile range 7.8, 16.6], respectively, P =.09). There were no significant differences in mode of delivery, rates of postpartum hemorrhage, chorioamnionitis, or epidural use. Both groups had similar rates of tachysystole as well as total oxytocin dose. There were no differences in neonatal birth weight, Apgar scores, cord gases, or admissions to the neonatal intensive care unit. CONCLUSION: This is the first randomized trial to compare concurrent Foley bulb/oxytocin vs oxytocin alone in nulliparous patients undergoing induction of labor for PROM. We found no difference in time from induction to delivery in patients induced with concurrent Foley bulb/oxytocin vs oxytocin alone. In nulliparous patients with PROM, this study suggests that addition of a Foley bulb to oxytocin does not decrease the time from induction start to delivery.