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Clinical Trial

Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement

NCT: NCT07689357 · RECRUITING

NCT IDNCT07689357
StatusRECRUITING
Start Date2026-05-27
Completion2028-11-01
SponsorRambam Health Care Campus (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement?

Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement is a clinical trial registered under NCT07689357. Current status: RECRUITING.

What is the status of NCT07689357?

The current status of NCT07689357 (Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement) is: RECRUITING.

When did Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement start?

Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement started on 2026-05-27.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.