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

University of Alabama at Birmingham169 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

169

Conditions

Fetal Membranes, Premature Rupture Labor, Induced/IS

Interventions

Transcervical Foley catheterDEVICE

Foley catheter placed through cervix for cervical ripening

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction 2. Cervix ≤ 2 centimeters (cm) 3. Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery 4. Singleton gestation 5. Cephalic 6. Vertex well applied to cervix Exclusion Criteria: 1. Regular uterine contractions (contractions more frequent than every 5 minutes) 2. Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor 3. Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge) 4. Lethal fetal anomalies 5. Intrauterine fetal demise (IUFD) 6. Previa 7. Suspected abruption/significant hemorrhage 8. Non-reassuring fetal heart rate (FHR) pattern 9. Non vertex fetal presentation

Locations (3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Christiana Care Health System

Newark, Delaware, United States

Greenville Hospital System University Medical Center

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

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 frame: Time from induction to delivery

Secondary Outcomes

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.

Time frame: 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.

Time frame: at delivery

Induction to Vaginal Delivery Interval

Mean hours from time of induction to vaginal delivery interval.

Time frame: time from induction to vaginal delivery, up to 24 hours

Data from ClinicalTrials.gov

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