Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial

Objective The aim of study is to compare, in a pilot study, combined dinoprostone vaginal insert and Foley catheter (DVI+Foley) with Foley alone (Foley) for cervical ripening and labor induction at term. Study Design In this open-label pilot randomized controlled trial, women not in labor, with intact membranes, no prior uterine incision, an unfavorable cervix, gestational age >= 37 weeks, and a live, nonanomalous singleton fetus in cephalic presentation were randomly assigned, stratified by parity, to DVI+Foley or Foley. Oxytocin was used in both groups after cervical ripening. Primary outcome was time to vaginal delivery. Results From April 2017 to January 2018, 100 women were randomized. Median (25-75th percentile) time to vaginal delivery for nulliparous women was 21.2 (16.6-38.0) hours with DVI+Foley ( n =26) compared with 31.3 (23.3-46.9) hours with Foley ( n =24) (Wilcoxon p =0.05). Median time to vaginal delivery for parous women was 17.1 (13.6-21.9) hours with DVI+Foley ( n =25) compared with 14.8 (12.7-19.5) hours with Foley ( n =25) (Wilcoxon p =0.21). Results were also analyzed to consider the competing risk of cesarean using cumulative incidence functions. Conclusion Compared with Foley alone, combined use of the dinoprostone vaginal insert and Foley for cervical ripening may shorten time to vaginal delivery for nulliparous but not parous women.