FOLCROM Trial: Foley Catheter in Rupture of Membranes

This is a prospective, randomized, multi-center clinical trial to test the hypothesis that in
women with term and near term premature rupture of membranes (PROM), an intrauterine Foley
catheter plus oxytocin infusion will decrease the mean time from induction to delivery by 2.5
hours as compared to oxytocin alone.

Inclusion Criteria:

1. Spontaneous rupture of membranes (ROM) ≥1 hour prior to starting induction; ROM
defined as clinical history with the presence of 2 of the following 4: pooling,
ferning, nitrazine, oligohydramnios. In the absence of clinical history,
oligohydramnios AND pooling must be present for ROM to be diagnosed. Oligohydramnios
is defined as a total amniotic fluid index of <5cm or a maximum vertical pocket <2cm.

2. Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced

3. Gestational age ≥ 34 weeks by best obstetric estimate

4. Clinical management decision is vaginal delivery

5. Singleton gestation

6. Cephalic presentation

7. Willing to participate and able to understand and sign the informed consent document
before randomization

8. Women of reproductive age

Exclusion Criteria:

1. Multiple gestations

2. Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18

3. Latex allergy

4. Greater than 1 prior cesarean delivery

5. Active labor - defined as contractions more frequent than every 5 minutes (or ≥ 12
contractions in 1 hour) associated with ≥ 1 cm cervical change. In the absence of ≥ 1
cm cervical change after 2 hours, patients with contractions can be included in the
study.

6. Suspicion of chorioamnionitis

7. Any contraindications to vaginal delivery, including malpresentation, active herpes,
complete placenta previa, greater than two prior cesarean deliveries, etc.

8. HIV positive status or AIDS

9. Intrauterine fetal demise

10. Suspected placental abruption, significant hemorrhage

11. Nonreassuring fetal heart rate (FHR) pattern

12. Participation in a competing trial