FOLCROM Trial: Foley Catheter in Rupture of Membranes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Foley Catheter Versus Oxytocin for Labor Induction in Women With Term and Near Term Premature Rupture of Membranes: A Randomized Clinical Trial (FOLCROM Trial)

Conditions
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Premature Rupture of Membranes

Intervention / Treatment
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* Device: Foley Catheter
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>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. | Drug: Oxytocin<br>* 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.<br>* Other names: Pitocin;|
| Experimental: Foley Catheter and Oxytocin<br>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. | Device: Foley Catheter<br>* 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.<br>* Other names: 30cc/16 French;Drug: Oxytocin<br>* 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.<br>* Other names: Pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from induction to delivery (average 14.2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 |  | 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 | 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. | Duration of Labor (average 4.8 hours) | 
| Rate of Endomyometritis | 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 | Duration of hospital stay (average 3.4 days) | 
| Maternal Length of Stay, From Admission to Discharge (Days) |  | Duration of hospital stay (average 3.4 days) | 
| Rate of Five Minute Apgar Score < 5 | 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. | Duration of hospital stay (average 3.4 days) | 
| Arterial Cord Blood Gas (pH), When Obtained |  | Within 1 hour of delivery | 
| Rate of Neonatal Sepsis | Neonatal sepsis [positive blood or cerebrospinal fluid (CSF) cultures] | Duration of hospital stay (average 3.4 days) | 
| 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 | Chorioamnionitis/funisitis as determined by the pathologist examining the placenta | Duration of hospital stay (average 3.4 days) | 
| Time From Induction to Delivery (Hours) | Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks | Time from induction to delivery (average 14.2 hours) | 
| Overall Cesarean Delivery |  | Duration of hospital stay (average 3.4 days) | 
| Rate of Chorioamnionitis | 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) | Duration of hospital stay (average 3.4 days) | 
| Maternal Length of Stay From Delivery to Discharge (Hours) |  | Duration of hospital stay (average 3.4 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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foley catheter, foley bulb, oxytocin