An interventional study of Cook Cervical Ripening Balloon 3 hours and Cook Cervical Ripening Balloon 12 hours in Labor Induction and Cervical Ripening and Induction of Labor, sponsored by Rambam Health Care Campus. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
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.
Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Double-balloon cervical ripening catheter inserted and left in place for 3 hours before removal
Device: Cook Cervical Ripening Balloon 3 hours
Double-balloon cervical ripening catheter inserted and left in place for 12 hours before removal
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 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 12 hours.
Insertion-to-Delivery Time Interval
The time interval (in hours) from the successful insertion of the cervical ripening balloon to the time of fetal delivery (whether vaginal or cesarean section).
Time frame: From the time of balloon insertion up to delivery (approximately 48 hours).
Mode of Delivery
The rates of successful vaginal deliveries, instrumental deliveries (vacuum), and cesarean deliveries between the two groups.
Time frame: At the time of delivery.
Time to Active Phase and Second Stage of Labor
The duration (in hours) from balloon insertion to the onset of the active phase of labor, and the duration of the second stage of labor.
Time frame: From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion.
Maternal Complications
Composite rate of maternal complications including chorioamnionitis, postpartum hemorrhage (PPH, defined as estimated blood loss greater than 1000 mL), need for blood transfusion, maternal fever during or after delivery, and obstetric anal sphincter injuries (OASIS).
Time frame: From balloon insertion up to 48 hours postpartum.
Adverse Neonatal Outcomes
Composite rate of neonatal outcomes including birthweight, Apgar scores at 1 and 5 minutes (range 0-10; higher scores indicate better neonatal condition), neonatal umbilical cord pH, rates of respiratory complications, admission to the Neonatal Intensive Care Unit (NICU), and suspected or confirmed neonatal sepsis.
Time frame: From birth up to newborn discharge or 7 days of life.
Duration of Hospitalization
The total length of maternal hospital stay (in days) from the day of admission for labor induction to the day of postpartum discharge.
Time frame: From admission for induction up to hospital discharge (approximately 3-5 days).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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