FOLCROM Trial: Foley Catheter in Rupture of Membranes

N/ACompletedNCT01973036

Geisinger Clinic201 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

201

Conditions

Premature Rupture of Membranes

Interventions

Foley CatheterDEVICE

The balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.

OxytocinDRUG

Each 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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Time From Induction of Labor Until Delivery

Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries

Time frame: Time from induction to delivery (average 14.2 hours)

Secondary Outcomes

Number of Participants With Chorioamnionitis

Number of participants with chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks. Chorioamnionitis was defined as temperature 38°C (or 100.4°F) or greater with at least two of the following: purulent discharge, maternal tachycardia (heart rate 100 beats per minute or greater), fetal tachycardia (heart rate 160 beats per minute or greater), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15,000 cells/mL3). Without Restriction = Chorioamnionitis was defined as temperature 38°C or greater and one of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis. With Restriction = Chorioamnionitis was defined as temperature 38°C or greater and two of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis.

Time frame: Duration of Labor (average 4.8 hours)

Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin

Time frame: Duration of Labor (average 4.8 hours)

Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin

Time frame: Duration of Labor (average 4.8 hours)

Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries

Time frame: Duration of Labor (average 4.8 hours)

Data from ClinicalTrials.gov

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