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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07689357). StuddyBuddy aggregates publicly available trial information.