Labor Induction After Failed Induction With Dinoprostone.
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Device: Cervical ripening balloon.Drug: Dinoprostone
- Registration Number
- NCT04597333
- Lead Sponsor
- Rambam Health Care Campus
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 144
- Women after induction of labor with Dinoprostone.
- BISHOP score of under 5 after 1st induction attempt.
- Nulliparous women.
- Women after induction of labor with a cervical ripening balloon.
- BISHOP score of over 5 after 1st induction attempt.
- Multiparous women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cervical ripening balloon. Cervical ripening balloon. Women induced with a cervical ripening balloon. 2nd Dinoprostone. Dinoprostone Women induced with a second dinoprostone insert.
- Primary Outcome Measures
Name Time Method Delivery within 24 hours. From the time of induction up to 24 hours from induction. Rate of delivery in 24 hours.
Time to delivery. From the time of induction up to 120 hours from induction. The number of hours it takes to deliver.
- Secondary Outcome Measures
Name Time Method Mode of delivery. From the time of induction up to 120 hours from induction. Vaginal and cesarean delivery rates.
Uterine revision. From the time of induction up to 120 hours from induction. The rate of uterine revision postpartum.
Postpartum hemorrhage. From the time of induction up to 120 hours from induction. The rate of postpartum hemorrhage.
Chorioamnionitis. From the time of induction up to 120 hours from induction. The rate of chorioamnionitis.
Trial Locations
- Locations (1)
Rambam health care campus
🇮🇱Haifa, Israel