N/A N=376 Randomized Treatment

Foley Catheter Versus Cervidil for Induction of Labor at Term

Labor Induction

Bottom Line

View on ClinicalTrials.gov: NCT01402050 ↗

Enrolled (actual)

376

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Time Of Start Of Induction Of Labor To Delivery — 21.6; 26.6 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CERVIDIL (Dinoprostone) (Drug); FOLEY BALLOON (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Pediatrix
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Time Of Start Of Induction Of Labor To Delivery	21.6; 26.6	—

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™).

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01402050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.