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Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low‐Bishop‐score pregnancy

Background. Dinoprostone vaginal insert has been compared to Dinoprostone cervical gel in few studies, whose cases presented different Bishop scores and gestational ages at admission, and various treatment strategies in control arms. The present study compares the vaginal insert to the cervical gel in patients with low Bishop score at term. Methods. Prospective multicenter randomized trial, with parity‐based randomization. Admission criteria: single pregnancy with Bishop score of 0–4, gestational age of 37–41 weeks, intact membranes, no previous cesarean section, no bleeding or abnormal cardiotocography at admission. Results. Vaginal prostaglandins were required as a second‐line induction procedure in 25% of study patients versus 47.1% of controls (p<0.03, κ2). Study patients experienced shorter induction‐to‐delivery time (920±428 versus 1,266±740 min, p<0,01), with a mean difference of 5 h and 46 min between the groups. Even though patients that received vaginal insert showed a trend of increased incidence of abnormal cardiotocography during labor (12% versus 6.3%) and hyperkinetic labor (11.8% versus 2.1%), the incidence of cesarean sections (21.4% versus 21.6%), cesareans for fetal distress (12.5% versus 11.8%), and umbilical artery pH < 7.10 (4.9% versus 2.5%) was comparable between the two groups. Conclusions. Dinoprostone vaginal insert is more efficient than cervical gel in promoting cervical priming and labor induction in low‐Bishop‐score patients at term. The vaginal insert placement seems to be safe for the mother and the newborn, although larger studies are required to investigate uterine hyperstimulation incidence.