FOLCROM Trial: Foley Catheter in Rupture of Membranes

Completed · Not applicable

Conditions studied: Premature Rupture of Membranes

In brief

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.

Key facts

Study ID

NCT01973036

Run by

Geisinger Clinic

People needed

201

Starts

2014-03-01

Expected to finish

2016-08-01

Last updated by the study team

2018-09-24

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Good Samaritan Regional Medical Center — Phoenix, Arizona, United States
• Christiana Care Health System CCHS — Newark, Delaware, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Geisinger Wyoming Valley — Wilkes-Barre, Pennsylvania, United States

Full record on ClinicalTrials.gov

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