Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture

The University of Alabama at Birmingham

Status: Terminated

Conditions: Labor, Induced/IS; Fetal Membranes, Premature Rupture

Treatments: Device: Transcervical Foley catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00290199

F051021005

Details and patient eligibility

About

In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.

Full description

To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at > 34 weeks.

Enrollment: 169 patients

Sex: Female

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
2. Cervix ≤ 2 centimeters (cm)
3. Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
4. Singleton gestation
5. Cephalic
6. Vertex well applied to cervix

Exclusion criteria

1. Regular uterine contractions (contractions more frequent than every 5 minutes)
2. Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
3. Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
4. Lethal fetal anomalies
5. Intrauterine fetal demise (IUFD)
6. Previa
7. Suspected abruption/significant hemorrhage
8. Non-reassuring fetal heart rate (FHR) pattern
9. Non vertex fetal presentation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 participants in 2 patient groups

Transcervical Foley Catheter

Experimental group

Treatment:

Device: Transcervical Foley catheter

No Foley

No Intervention group