Cervical Ripening Balloon for 12 Hours vs. 1 Hour.
ConditionInduction of Labor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorRambam Health Care Campus
About this trial
The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.
Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.
Eligibility criteria
Qualifiers
Nulliparous or multiparous gravidas
Gestational age ≥ 370/7 to 416/7 gestational weeks
Age 18-45
Signed informed consent
Disqualifiers
Contraindications for vaginal delivery
Multifetal gestation
Rupture of membranes
Bishop score > 6
Trial design
Treatments tested in this trial
- cervical ripening balloon for one hour
- cervical ripening balloon for twelve hours
Treatment groups
164 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov