American Journal of Obstetrics and Gynecology
Poster Session IIThursday, February 1 • 4:00 PM - 5:30 PM • Trinity Exhibit Hall401: Cervical ripening with a double balloon catheter for first vaginal delivery: 6 versus 12 hours: A randomized control trial
Section snippets
Objective
To evaluate whether shortening the length of transcervical double balloon catheter use from 12 hours to 6 hours shortens the duration of induction by at least 4 hours in patients undergoing a first vaginal delivery.
Study Design
In a prospective randomized trial, women received a transcervical double balloon catheter for either 6 or 12 hours. The primary outcome was time from catheter placement until delivery. Secondary outcomes included rate of c-section and time from catheter placement to extrusion. A sample size of 200 was calculated to detect a 4 hour difference in time to delivery, based on a power of 0.80.
Results
From October 2015 through October 2016, 451 women were screened and 204 women agreed to participate in the study. 102 women were randomized to each arm of the study. Four of these patients were excluded secondary to inclusion and exclusion criteria, two patients in each arm. The baseline characteristics of both groups were similar. The time to delivery was 24.2 hours in the 6 hour group and 24.6 hours in the 12 hour group, with a p-value of 0.80. A sub-group analysis was performed of the group
Conclusion
In this study, we found that shortening the length of foley bulb use from 12 to 6 hours was not associated with a shorter time to delivery in patients undergoing first vaginal delivery. Cesarean section rate, rate of maternal infection, and neonatal outcomes were the same for both groups. Importantly, using the foley bulb for only 6 hours was not associated with an increased rate of c-section or failure to progress. In our subgroup analysis of patients undergoing trial of labor after cesarean