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Cervical Ripening Balloon for 12 Hours vs. 1 Hour.
Sponsor: Rambam Health Care Campus
Summary
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.
Official title: Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2023-08-01
Completion Date
2026-06-30
Last Updated
2023-06-28
Healthy Volunteers
Yes
Conditions
Interventions
cervical ripening balloon for one hour
The 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
The 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