Status:
TERMINATED
Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both
Lead Sponsor:
Bnai Zion Medical Center
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The aim of this study is to compare the rate of cesarean delivery between 3 methods of labor induction: double balloon device, oral misoprostol and combination of the two.
Detailed Description
Induction of labor is a common obstetrical procedure. It accounts for 20% of laboring women worldwide. In the past, studies showed that cesarean delivery rates (CDR) are higher in women who are induc...
Eligibility Criteria
Inclusion
- unfavourable cervix (Bishop score ≤ 4),
- indication for induction of labor (medical or obstetrical),
- 37 completed gestational weeks,
- vertex presentation,
- singleton pregnancy
- intact membranes.
Exclusion
- previous cesarean delivery
- previous uterine surgery (eg: myomectomy)
- noncephalic presentation
- multiple pregnancy
- pre-eclampsia with severe features
- oligohydramnios (Maximal vertical pocket ≤2)
- estimated fetal weight \<10% percentile
- any contraindication to Vaginal delivery
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03866772
Start Date
June 1 2019
End Date
September 24 2023
Last Update
October 30 2023
Active Locations (1)
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1
Bnai Zion Mc
Haifa, Israel