FOLCROM Trial: Foley Catheter in Rupture of Membranes (FOLCROM)
Premature Rupture of Membranes
About this trial
This is an interventional treatment trial for Premature Rupture of Membranes focused on measuring foley catheter, foley bulb, oxytocin
Eligibility Criteria
Inclusion Criteria:
- 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.
- Unfavorable cervix, defined as sterile digital exam ≤ 2cm dilated / 80% effaced
- Gestational age ≥ 34 weeks by best obstetric estimate
- Clinical management decision is vaginal delivery
- Singleton gestation
- Cephalic presentation
- Willing to participate and able to understand and sign the informed consent document before randomization
- Women of reproductive age
Exclusion Criteria:
- Multiple gestations
- Lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18
- Latex allergy
- Greater than 1 prior cesarean delivery
- 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.
- Suspicion of chorioamnionitis
- Any contraindications to vaginal delivery, including malpresentation, active herpes, complete placenta previa, greater than two prior cesarean deliveries, etc.
- HIV positive status or AIDS
- Intrauterine fetal demise
- Suspected placental abruption, significant hemorrhage
- Nonreassuring fetal heart rate (FHR) pattern
- Participation in a competing trial
Sites / Locations
- Banner Good Samaritan Regional Medical Center
- Christiana Care Health System CCHS
- Lehigh Valley Hospital
- Geisinger Medical Center
- Geisinger Wyoming Valley
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Oxytocin
Foley Catheter and Oxytocin
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.
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.