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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
cervical ripening balloon for one hour
DeviceThe cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
cervical ripening balloon for twelve hours
DeviceThe cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: cervical ripening balloon for 1 hourExperimental treatment 1 intervention
Group B: cervical ripening balloon for 12 hoursActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
insertion to delivery time interval
The time interval between balloon insertion to delivery
Time frame
From date of balloon insertion until the date of delivery, assessed up to 4 daysSecondary outcomes
1
to compare the mode of delivery
Mode of delivery
Time frame
From date of balloon insertion until the date of delivery, assessed up to 4 days2
to compare the time to active and second stage of labor
Time to active and second stage of labor
Time frame
From date of balloon insertion until the date of delivery, assessed up to 4 days3
to compare the rate of chorioamnionitis
Rate of chorioamnionitis
Time frame
From date of balloon insertion until the date of discharge, assessed up to 8 days4
to compare the rate of post-partum hemorrhage
Rate of post-partum hemorrhage and need for blood transfusion
Time frame
From date of balloon insertion until the date of discharge, assessed up to 8 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: