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Abstract
Objective
Cervical ripening by mechanical methods enhances labor induction success. We compared Cervical Ripening Double Balloon catheter (CRDB) to Foley catheter.
Study design
This prospective blind study randomized 85 nulliparas and 95 multiparas to labor induction by either Foley catheter or CRDB. Primary outcomes were Bishop score increment, time from catheter withdrawal to delivery, and cesarean section rate.
Results
In multiparas, mean Bishop score increment between pre- and post-catheter was significantly higher in the CRDB catheter than in the Foley group (4.4 ± 1.9 and 3.4 ± 2.0, respectively, p = .02). Mean interval from catheter withdrawal to delivery was shorter in the CRDB catheter (14.6 ± 12.3 and 8.6 ± 5.4) than in the Foley catheter group (22.6 ± 27.2 and 13.9 ± 17.7), in both nulliparas and multiparas (p = .05 and p = .03, respectively). In nulliparas, no statistically significant differences were found in mean Bishop score increment between the two catheters, but cesarean section rate was higher in the Foley group than the CRDB group (46.5% and 20%, respectively, p = .02).
Conclusion
Bishop score increment by CRDB catheter is more effective than induction by Foley catheter in multiparas. CRDB catheter is associated with decreased time to delivery in both nulliparas and multiparas and a lower cesarean section rate in nulliparas.
ClinicalTrials.gov Identifier: NCT00501033
Acknowledgments
The authors would like to thank the late Vladimir Sosnovsky MD, Ms. Tobie Kuritsky, Ms. Cindy Cohen and Ms. Orly Yakir for their assistance.
Disclosure statement
No potential conflict of interest was reported by the authors.