Clinical Trial

Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement

Recruiting
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Summary
The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor. The main questions it aims to answer are: Does placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement? Does a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort? Researchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery. Participants will: Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours). Undergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion. Have the balloon removed after approximately 3 hours or 12 hours depending on their assigned group. Proceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician. Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.
Trial Details
NCT Number NCT07689357
Lead Sponsor Rambam Health Care Campus
Conditions Labor Induction, Cervical Ripening and Induction of Labor
Enrollment 164 participants
Start Date 2026-05-27
Primary Completion 2028-06-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-08