A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter

OBJECTIVE: We sought to compare the efficacy of a double-balloon transcervical catheter to that of a prostaglandin (PG) vaginal insert among women undergoing labor induction. STUDY DESIGN: In all, 210 women with a Bishop score <6 were assigned randomly to cervical ripening with either a double-balloon device or a PGE2 sustained-release vaginal insert. Primary outcome was vaginal delivery within 24 hours. RESULTS: The proportion of women who achieved vaginal delivery in 24 hours was higher in the double-balloon group than in the PGE2 group (68.6% vs 49.5%; odds ratio, 2.22; 95% confidence interval, 1.26-3.91). There was no difference in cesarean delivery rates (23.8% vs 26.2%; odds ratio, 0.88; 95% confidence interval, 0.47-1.65). Oxytocin and epidural analgesia were administered more frequently when a double-balloon device was used. Uterine tachysystole or hypertonus occurred more frequently in the PGE2 arm (9.7% vs 0%, P=.0007). CONCLUSION: The use of a double-balloon catheter for cervical ripening is associated with a higher rate of vaginal birth within 24 hours compared with a PGE2 vaginal insert.