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

Not Applicable

Terminated

• Conditions: Fetal Membranes, Premature Rupture; Labor, Induced/IS
• Interventions: Device: Transcervical Foley catheter

• Registration Number: NCT00290199
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2012-06-01
• Results First Submitted QC: 2012-09-29
• Results First Posted: 2012-10-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcervical Foley Catheter	Transcervical Foley catheter	-

Primary Outcome Measures

Name	Time	Method
Hours From Placement of Foley or Initiation of Oxytocin to Delivery	Time from induction to delivery	The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)

Secondary Outcome Measures

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

Trial Locations

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