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Study identifier: NCT07689357 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement

Condition: Labor Induction · Cervical Ripening and Induction of Labor  ·  Sponsor: Rambam Health Care Campus

PhaseNA
Planned participants164
Who can joinFemale, 18 Years to 45 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (1)

Rambam Health Care CampusHaifa, IsraelRecruiting

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Source record: clinicaltrials.gov/study/NCT07689357