Labor induction with a combined method (pharmacologic and mechanical): A randomized controlled trial

Introduction: The aim of this study was to compare the effectiveness of a combined misoprostol-Foley catheter induction of labor protocol against the current guidelines of our department. Material and methods: A randomized trial was conducted comparing two cervical ripening study groups: combined misoprostol-cervical Foley and the current department practice (misoprostol alone or dinoprostone alone). Women were stratified randomly according to parity for the two intervention groups. The primary outcome was defined as time to delivery (in hours). Secondary outcomes were cesarean delivery rate, time to active labor (defined as dilatation 6 cm or greater), delivery within 12 h, delivery within 24 h, maternal length of stay and indication for cesarean delivery. A composite of maternal morbidity and neonatal morbidity were also analyzed. Results: 142 women were randomized into one of the two groups (74 for treatment group and 68 for control group). Demographic and clinical characteristics were similar among the two groups. The primary outcome, the average time to delivery, was faster in the treatment group (22.7 h vs 27.2 h, p = 0.03) and this difference was higher in the nulliparous subgroup (24.2 h vs 29.2 h, p = 0.03). Active phase of labor was achieved faster in the treatment group (17.9 h vs 22.7 h, p = 0.008). The risk for cesarean section was similar in both groups (OR 0.801 (0.527-1.217) vs OR 1.203 (0.871-1.662), p = 0.278). Conclusions: Our study suggests that the combined method of cervical Foley with vaginal misoprostol for women presenting to induction of labor with unfavorable Bishop scores reduces time to delivery safely. The risk for cesarean section was similar in both groups.