Cervical Ripening With a Double-Lumen Balloon Catheter for 6 Compared With 12 Hours: A Randomized Controlled Trial [216]. (May 2015)

• Record Type: Journal Article
• Authors: Mattingly, Patricia Jane; Temming, Lorene A.; Bliss, Susan A.
• Is Part Of: Obstetrics and gynecology. Volume 125(2015)Supplement 1
• Publication Date: 2015-05
• Subjects: Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1097/01.AOG.0000463120.78548.be
• Languages: English
• ISSNs: 0029-7844

Abstract

Abstract : OBJECTIVE: Induction of labor is commonly performed with a double-lumen balloon catheter, which is standardly left in place for a maximum of 12 hours. The objective of this study was to determine whether shortening the maximum placement time of a double-lumen balloon catheter from 12 to 6 hours could shorten time to delivery. METHODS: A randomized controlled trial was performed at an academic tertiary care institution between August 2013 and July 2013. Women were randomized to either 6 or 12 hours with removal at the predetermined time if it had not previously been spontaneously expelled. Wilcoxon rank-sum, χ 2, Fisher's exact, and Student's t tests were used for data analysis. Multivariate analysis was used to control for potential confounders. RESULTS: A total of 108 women were enrolled: 55 in the 6-hour arm and 53 in the 12-hour arm. Baseline demographics were comparable between the two groups. The mean time to delivery was 22.89 hours (±9.63) in the 12-hour arm and 20.19 hours (±9.85) in the 6-hour arm with a trend toward significance in the groups ( P <.075). CONCLUSION: There was a trend toward shorter induction time in those with a balloon catheter in place for 6 hours. The study was powered to demonstrate a 6-hour difference and a larger sample size is needed to demonstrate a statically significant 3-hour difference. Given the cost and discomfort associated with induction, health care providers can consider shorter placement time for a cervical balloon catheter. This may shorten time to delivery.