OBJECTIVE: We sought to compare the efficacy of the double-balloon catheter and dinoprostone for induction of labor among nulliparous women with an unfavorable cervix. STUDY DESIGN:Nulliparous women with a Bishop score <6 were randomized to receive a 10-mg intra-vaginal dinoprostone insert or a double-balloon catheter. Primary outcome was time to delivery. Statistical analyses were performed by intention to treat using the chi-square, Fisher's exact, and Student's t-test, as appropriate. RESULTS: The mean induction-to-delivery time was shorter in the double-balloon group as compared to the dinoprostone group (17.9±5.8 vs. 26.3±9.7 h) as was the time from induction to vaginal delivery (19.13±5 vs. 24.45±8.7 h, respectively). More women in the catheter group were delivered within 24 h compared to the dinoprostone group (87.1% vs. 47.4%). Approximately 50% of women in both groups delivered by cesarean section. CONCLUSION: Induction of labor with the double-balloon catheter in nulliparous women with an unfavorable cervix is associated with a shorter time to delivery compared to dinoprostone.
RCT Entities:
OBJECTIVE: We sought to compare the efficacy of the double-balloon catheter and dinoprostone for induction of labor among nulliparous women with an unfavorable cervix. STUDY DESIGN: Nulliparous women with a Bishop score <6 were randomized to receive a 10-mg intra-vaginal dinoprostone insert or a double-balloon catheter. Primary outcome was time to delivery. Statistical analyses were performed by intention to treat using the chi-square, Fisher's exact, and Student's t-test, as appropriate. RESULTS: The mean induction-to-delivery time was shorter in the double-balloon group as compared to the dinoprostone group (17.9±5.8 vs. 26.3±9.7 h) as was the time from induction to vaginal delivery (19.13±5 vs. 24.45±8.7 h, respectively). More women in the catheter group were delivered within 24 h compared to the dinoprostone group (87.1% vs. 47.4%). Approximately 50% of women in both groups delivered by cesarean section. CONCLUSION: Induction of labor with the double-balloon catheter in nulliparous women with an unfavorable cervix is associated with a shorter time to delivery compared to dinoprostone.
Authors: Marieke Dt de Vaan; Mieke Lg Ten Eikelder; Marta Jozwiak; Kirsten R Palmer; Miranda Davies-Tuck; Kitty Wm Bloemenkamp; Ben Willem J Mol; Michel Boulvain Journal: Cochrane Database Syst Rev Date: 2019-10-18