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

Primary Purpose

Fetal Membranes, Premature Rupture, Labor, Induced/IS

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcervical Foley catheter
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Membranes, Premature Rupture focused on measuring Fetal Membranes, Premature Rupture, Labor, Induced, Foley Catheter

Eligibility Criteria

12 Years - 55 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Christiana Care Health System
  • Greenville Hospital System University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transcervical Foley Catheter

No Foley

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Cesarean Rate
The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.
Induction to Vaginal Delivery Interval
Mean hours from time of induction to vaginal delivery interval.

Full Information

First Posted
February 9, 2006
Last Updated
April 12, 2017
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00290199
Brief Title
Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
Official Title
A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Gathering information from the PI records to provide this response.
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Membranes, Premature Rupture, Labor, Induced/IS
Keywords
Fetal Membranes, Premature Rupture, Labor, Induced, Foley Catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcervical Foley Catheter
Arm Type
Experimental
Arm Title
No Foley
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Transcervical Foley catheter
Intervention Description
Foley catheter placed through cervix for cervical ripening
Primary Outcome Measure Information:
Title
Hours From Placement of Foley or Initiation of Oxytocin to Delivery
Description
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 Outcome Measure Information:
Title
Rate of Delivery (Vaginal or Cesarean)by 24 Hours
Description
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
Title
Cesarean Rate
Description
The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.
Time Frame
at delivery
Title
Induction to Vaginal Delivery Interval
Description
Mean hours from time of induction to vaginal delivery interval.
Time Frame
time from induction to vaginal delivery, up to 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan T Tita, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Greenville Hospital System University Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9692332
Citation
Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986.
Results Reference
background

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

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