Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cook Cervical Ripening Balloon 3 hours, Cook Cervical Ripening Balloon 12 hours.
- Who it may be relevant to
- Registry conditions: Labor Induction, Cervical Ripening and Induction of Labor. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Labor Induction With Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement: a Randomized Controlled Trail
Overview
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.
Interventions
- Device Cook Cervical Ripening Balloon 3 hours
Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 3 hours. - Device Cook Cervical Ripening Balloon 12 hours
Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 12 hours.
Primary outcome measures
- Insertion-to-Delivery Time Interval [Time frame: From the time of balloon insertion up to delivery (approximately 48 hours).]
Secondary outcome measures (5)
- Mode of Delivery [Time frame: At the time of delivery.]
- Time to Active Phase and Second Stage of Labor [Time frame: From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion.]
- Maternal Complications [Time frame: From balloon insertion up to 48 hours postpartum.]
- Adverse Neonatal Outcomes [Time frame: From birth up to newborn discharge or 7 days of life.]
- Duration of Hospitalization [Time frame: From admission for induction up to hospital discharge (approximately 3-5 days).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Rambam Health Care Campus — Haifa
Identifiers
NCT: NCT07689357 · 0602-21-RMB