Status:
COMPLETED
Foley Catheter Versus Cervidil for Induction of Labor at Term
Lead Sponsor:
Pediatrix
Conditions:
Labor Induction
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induct...
Detailed Description
BACKGROUND: Induction of labor is performed in 25% of all women who present for delivery at the Banner Good Samaritan Medical Center (1). The commonality of labor induction is not only a local issue....
Eligibility Criteria
Inclusion
- Cervix \< 3 cm dilated. If 2cm dilated, must be \< 80% effaced.
- Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
- Singleton gestation
- Cephalic presentation
Exclusion
- Regular uterine contractions (more frequent than every 5 minutes)
- PROM
- Prior transverse uterine incision or any obstetric contraindication to labor
- Fever (defined as a temperature of 38°C or higher)
- Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
- Fetal death
- Placenta previa
- Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
- Non-reassuring fetal heart rate pattern
- HIV
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT01402050
Start Date
June 1 2010
End Date
February 1 2015
Last Update
March 2 2020
Active Locations (2)
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1
Banner Desert Medical Center
Mesa, Arizona, United States, 85210
2
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006