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

A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)

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.

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.

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