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NCT07689357
Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement
Conditions: Labor Induction, Cervical Ripening and Induction of Labor
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 164
Sponsor: Rambam Health Care Campus
Location: Rambam Health Care Campus Haifa
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.
Eligibility Criteria
Inclusion Criteria:
* Nulliparous or multiparous pregnant women.
* Gestational age between 37 0/7 and 41 6/7 weeks of gestation.
* Maternal age between 18 and 45 years.
* Participant has provided signed informed consent.
Exclusion Criteria:
* Presence of any contraindications for vaginal delivery.
* Multifetal gestation.
* Rupture of membranes prior to balloon insertion.
* Favorable cervix, defined as a Bishop score greater than 6.
* Cervical dilation greater than 2 cm.
* Previous cesarean delivery or any other prior major uterine surgery.
Source: ClinicalTrials.gov (NCT07689357). StuddyBuddy aggregates publicly available trial information.