Foley Catheter Versus Cervidil for Induction of Labor at Term

Completed · Not applicable

Conditions studied: Labor Induction

In brief

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™).

Key facts

Study ID

NCT01402050

Run by

Pediatrix

People needed

376

Starts

2010-06-01

Expected to finish

2015-02-01

Last updated by the study team

2020-03-02

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Desert Medical Center — Mesa, Arizona, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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