Comparison of Cervical Ripening Balloon Versus 2nd Dinoprostone Insert for Labor Induction in Women With a Failed 1st Attempt of Induction With Dinoprostone.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Delivery within 24 hours.
Study Overview
Brief Summary
Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.
Detailed Description
Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women after induction of labor with Dinoprostone.
- •BISHOP score of under 5 after 1st induction attempt.
- •Nulliparous women.
Exclusion Criteria
- •Women after induction of labor with a cervical ripening balloon.
- •BISHOP score of over 5 after 1st induction attempt.
- •Multiparous women.
Arms & Interventions
2nd Dinoprostone.
Women induced with a second dinoprostone insert.
Intervention: Dinoprostone (Drug)
Cervical ripening balloon.
Women induced with a cervical ripening balloon.
Intervention: Cervical ripening balloon. (Device)
Outcomes
Primary Outcomes
Delivery within 24 hours.
Time Frame: From the time of induction up to 24 hours from induction.
Rate of delivery in 24 hours.
Time to delivery.
Time Frame: From the time of induction up to 120 hours from induction.
The number of hours it takes to deliver.
Secondary Outcomes
- Mode of delivery.(From the time of induction up to 120 hours from induction.)
- Uterine revision.(From the time of induction up to 120 hours from induction.)
- Postpartum hemorrhage.(From the time of induction up to 120 hours from induction.)
- Chorioamnionitis.(From the time of induction up to 120 hours from induction.)
Investigators
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus