Overview
Foley Catheter Versus Cervidil for Induction of Labor at Term
Status:
Completed
Completed
Trial end date:
2015-02-01
2015-02-01
Target enrollment:
0
0
Participant gender:
Female
Female
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 induction. HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Mednax Center for Research, Education and QualityMednax Center for Research, Education, Quality and Safety
Treatments:
DinoprostoneCriteria
Inclusion Criteria:1. Cervix < 3 cm dilated. If 2cm dilated, must be < 80% effaced.
2. Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management
decision is delivery.
3. Singleton gestation
4. Cephalic presentation
Exclusion Criteria:
1. Regular uterine contractions (more frequent than every 5 minutes)
2. PROM
3. Prior transverse uterine incision or any obstetric contraindication to labor
4. Fever (defined as a temperature of 38°C or higher)
5. Lethal fetal anomalies (Labor induction is being performed, but there is no plan for
fetal heart rate monitoring or cesarean delivery for fetal indications.)
6. Fetal death
7. Placenta previa
8. Suspected placental abruption or undiagnosed bleeding characterized as more than
"spotting"
9. Non-reassuring fetal heart rate pattern
10. HIV