FOLCROM Trial: Foley Catheter in Rupture of Membranes

Not Applicable

Completed

• Conditions: Premature Rupture of Membranes
• Interventions: Device: Foley Catheter; Drug: Oxytocin

• Registration Number: NCT01973036
• Lead Sponsor: Geisinger Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Study Start: 2014-03
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Results First Submitted: 2018-05-16
• Status Verified: 2018-07
• Results First Submitted QC: 2018-09-20
• Last Update Submitted: 2018-09-20
• Results First Posted: 2018-09-24
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley Catheter and Oxytocin	Foley Catheter	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.
Oxytocin	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.
Foley Catheter and Oxytocin	Oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Time From Induction of Labor Until Delivery	Time from induction to delivery (average 14.2 hours)	Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries

Secondary Outcome Measures

Name	Time	Method
Rate of Endomyometritis	Duration of hospital stay (average 3.4 days)	Endomyometritis defined as: Temperature ≥100.4°F + one of the following: fundal tenderness, maternal tachycardia (Heart Rate ≥ 100 BPM), purulent cervical discharge and no other source of fever
Maternal Length of Stay, From Admission to Discharge (Days)	Duration of hospital stay (average 3.4 days)
Number of Participants With Chorioamnionitis	Duration of Labor (average 4.8 hours)	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.
Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin	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	Duration of Labor (average 4.8 hours)
Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries	Duration of Labor (average 4.8 hours)
Rate of Failed Induction of Labor as the Indication for Cesarean	Duration of Labor (average 4.8 hours)	This will be defined by a combination of provider documentation and cervical dilation of ≤4cm/90% effaced or ≤5cm/any effacement after a minimum of 12 hours of oxytocin in the setting of adequate contraction.; One patient was missing information for failed induction.
Rate of Five Minute Apgar Score < 5	Duration of hospital stay (average 3.4 days)	Apgar is a test for assessing a newborn shortly after birth to determine if extra medical care or emergency care may be needed. Usually administered at 1 and 5 minutes after birth, the test includes assessment of Appearance, Pulse, Grimace, Activity and Respiration. Scores range from 0 - 10.
Arterial Cord Blood Gas (pH), When Obtained	Within 1 hour of delivery
Rate of Neonatal Sepsis	Duration of hospital stay (average 3.4 days)	Neonatal sepsis \[positive blood or cerebrospinal fluid (CSF) cultures\]
Neonatal Intensive Care Unit (NICU) Admission Rate	Duration of hospital stay (average 3.4 days)
Neonatal Length of Stay	Duration of hospital stay (average 3.4 days)
Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis	Duration of hospital stay (average 3.4 days)	Chorioamnionitis/funisitis as determined by the pathologist examining the placenta
Time From Induction to Delivery (Hours)	Time from induction to delivery (average 14.2 hours)	Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks
Overall Cesarean Delivery	Duration of hospital stay (average 3.4 days)
Rate of Chorioamnionitis	Duration of hospital stay (average 3.4 days)	Chorioamnionitis defined as (Temperature greater than or equal to 100.4 degrees fahrenheit or 38 degrees celsius) with at least 2 of the following: uterine tenderness, maternal tachycardia (HR greater than or equal to 100 bpm), fetal tachycardia (HR greater than or equal to 160bpm), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15000 cells/cubic milliliter)
Maternal Length of Stay From Delivery to Discharge (Hours)	Duration of hospital stay (average 3.4 days)

Trial Locations

Locations (5)

Banner Good Samaritan Regional Medical Center; 🇺🇸 Phoenix, Arizona, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

Christiana Care Health System CCHS; 🇺🇸 Newark, Delaware, United States

Geisinger Wyoming Valley; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States