NCT07689357 Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement
| NCT ID | NCT07689357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rambam Health Care Campus |
| Condition | Labor Induction |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2026-05-27 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT07689357 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Labor Induction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07689357 currently recruiting?
Yes, NCT07689357 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rambam Health Care Campus to inquire about joining.
Where is the NCT07689357 trial being conducted?
This trial is being conducted at Haifa, Israel.
Who is sponsoring the NCT07689357 clinical trial?
NCT07689357 is sponsored by Rambam Health Care Campus. The trial plans to enroll 164 participants.