Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorRambam Health Care Campus
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cook Cervical Ripening Balloon 3 hours
DeviceUse 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.
Cook Cervical Ripening Balloon 12 hours
DeviceUse 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.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: 3 hours balloon groupExperimental treatment 1 intervention
Group B: 12 hours balloon groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov