Randomized Trial Comparing 3-Hour Versus 12-Hour Cervical Ripening Balloon Placement for Labor Induction in Pregnant Women

What this Trial Is About

This clinical trial focuses on pregnant women undergoing labor induction to determine if a shorter duration of cervical ripening balloon placement can reduce the time to delivery. The study aims to compare the effects of placing the balloon for 3 hours or less versus the standard 12-hour placement. Researchers also want to see if the shorter placement leads to better pregnancy outcomes, fewer complications, and less maternal discomfort. Participants will be randomly assigned to one of two groups one group will have a double-lumen Cook cervical ripening balloon inserted and removed after approximately 3 hours, while the other group will have the same balloon inserted and removed after about 12 hours. Following balloon removal, labor may continue with amniotomy or Pitocin based on the labor and delivery physicians judgment. Throughout the study, participants will complete a Birth Satisfaction Scale questionnaire. Maternal and neonatal health outcomes will be monitored using hospital records. The primary outcome is the time interval from balloon insertion to delivery, which is tracked up to approximately 48 hours. Secondary outcomes include mode of delivery, time to active labor phases, maternal complications, neonatal outcomes, and hospitalization duration. The study is expected to last until late 2028.

Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement