Oral Concurrent 2 Thursday, February 14 • 1:15 PM - 4:00 PM • Augustus Ballroom 3-4 • Caesars Palace| Volume 220, ISSUE 1, SUPPLEMENT , S19-S20, January 01, 2019

22: Transcervical ballon+vaginal misoprostol versus misoprostol for cervical ripening in nulliparous-obese women: a multicenter randomized trial


      Nulliparous obese women are at increased risk for labor induction (IOL), unplanned cesarean delivery (CD) and adverse obstetric outcomes. Obesity has been associated with lower local prostaglandin sensitivity for cervical ripening. Our objective was to determine whether the combination of a transcervical Foley balloon and misoprostol (PGE1) is superior to PGE1 alone in decreasing the rate of CD in this population.

      Study Design

      Pragmatic, multicenter, randomized, comparative-effectiveness trial (RCT, NCT02813551) of nulliparous obese (BMI ≥30 kg/m2) women undergoing IOL from January 2016 to June 2018 at three academic hospitals. Inclusion criteria were: cephalic singleton gestation, intact membranes, gestational age ≥32 wks, and Bishop score (BS) <7. Major fetal anomalies, stillbirth or contraindications to PGE1 were excluded. Women were allocated to either 25 mcg of PGE1 plus a 26-Fr 60cc Foley balloon vaginally or 25 mcg of vaginal PGE1 alone every 4 h or until a BS >6 was achieved. Further labor management was at discretion of treating physicians. Primary outcome was rate of CD. Relevant secondary outcomes included: time from IOL to delivery, rate of composite maternal and neonatal outcomes. Sample size was determined based on a preliminary CD rate of 53%, with 80% power and alpha error of 0.05. Analyses were based on intention-to-treat.


      Of the 236 women randomized, 113 (48%) received combined Foley balloon plus vaginal PGE1 and 123 (52%) received PGE1 alone. Baseline characteristics were analogous. Most common indications for IOL are depicted in Table 1. There was no difference in rate of CD between groups (45% vs 43%, p=0.75), and no differences in indications for CD (Table1). No differences were noted in the duration from IOL to delivery (24.82 ± 13.76 h vs 24.5 ± 14.0 h, p=0.87). In addition, the rate of composite maternal and neonatal adverse outcomes was similar (Table 2). There were no maternal or neonatal deaths.


      In this RCT of nulliparous obese women, the rate of CD was similar irrespective of using vaginal PGE1 alone or in combination with a Foley balloon for IOL. Additional studies comparing different induction strategies are warranted.
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