Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture

Study Overview
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Brief Summary
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In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.

Detailed Description
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To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at > 34 weeks.

Official Title
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A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)

Conditions
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Fetal Membranes, Premature Rupture, Labor, Induced/IS

Intervention / Treatment
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* Device: Transcervical Foley catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction Cervix ≤ 2 centimeters (cm) Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery Singleton gestation Cephalic Vertex well applied to cervix Exclusion Criteria: Regular uterine contractions (contractions more frequent than every 5 minutes) Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge) Lethal fetal anomalies Intrauterine fetal demise (IUFD) Previa Suspected abruption/significant hemorrhage Non-reassuring fetal heart rate (FHR) pattern Non vertex fetal presentation

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Transcervical Foley Catheter<br> | Device: Transcervical Foley catheter<br>* Foley catheter placed through cervix for cervical ripening<br>|
| No Intervention: No Foley<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours From Placement of Foley or Initiation of Oxytocin to Delivery | The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours) | Time from induction to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Delivery (Vaginal or Cesarean)by 24 Hours | The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours. | from start of induction to 24 hours post start of induction | 
| Cesarean Rate | The percent of subjects enrolled who had a cesarean at any time for any reason for delivery. | at delivery | 
| Induction to Vaginal Delivery Interval | Mean hours from time of induction to vaginal delivery interval. | time from induction to vaginal delivery, up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal Membranes, Premature Rupture, Labor, Induced, Foley Catheter