FOLCROM Trial: Foley Catheter in Rupture of Membranes

Geisinger Health

Status: Completed

Conditions: Premature Rupture of Membranes

Treatments: Device: Foley Catheter; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01973036

2013-0379

Details and patient eligibility

About

Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.

Full description

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.

Enrollment: 201 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Oxytocin

Active Comparator group

Description:

This arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.

Treatment:

Drug: Oxytocin

Foley Catheter and Oxytocin

Experimental group

Description:

A 30cc/16 French (16F) foley catheter will be inserted by the provider under direct visualization or by palpation, ensuring that the catheter is appropriately and adequately positioned. Oxytocin will be administered concurrently at a rate of 2 milliunits/milliliter (as noted under oxytocin active comparator). If the catheter remains in place after 12 hours, it will be deflated and removed and oxytocin infusion will continue.

Treatment:

Drug: Oxytocin

Device: Foley Catheter