N/A
Completed N=376
Foley Catheter Versus Cervidil for Induction of Labor at Term
Labor Induction
Source: ClinicalTrials.gov NCT01402050 ↗
Enrolled (actual)
376
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Time Of Start Of Induction Of Labor To Delivery — 21.6; 26.6 hours
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™).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Of Start Of Induction Of Labor To Delivery |
21.6; 26.6 | — |
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
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. Informational only — not medical advice.