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
Qualifiers
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
Treatments tested in this trial
- Cook Cervical Ripening Balloon 3 hours
- Cook Cervical Ripening Balloon 12 hours
Treatment groups
164 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov