Foley Catheter Versus Cervidil for Induction of Labor at Term

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: 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/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mednax Center for Research, Education and Quality; Mednax Center for Research, Education, Quality and Safety
• Treatments: Dinoprostone

Criteria

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