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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290199
Recruitment Status : Terminated (Gathering information from the PI records to provide this response.)
First Posted : February 10, 2006
Results First Posted : October 31, 2012
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Alan Tita, 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.

Condition or disease Intervention/treatment Phase
Fetal Membranes, Premature Rupture Labor, Induced/IS Device: Transcervical Foley catheter Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transcervical Foley Catheter Device: Transcervical Foley catheter
Foley catheter placed through cervix for cervical ripening
No Intervention: No Foley

Primary Outcome Measures :
  1. Hours From Placement of Foley or Initiation of Oxytocin to Delivery [ Time Frame: 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 :
  1. Rate of Delivery (Vaginal or Cesarean)by 24 Hours [ Time Frame: 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.

  2. Cesarean Rate [ Time Frame: at delivery ]
    The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.

  3. Induction to Vaginal Delivery Interval [ Time Frame: time from induction to vaginal delivery, up to 24 hours ]
    Mean hours from time of induction to vaginal delivery interval.

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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290199

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19713
United States, South Carolina
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Alan T Tita, MD University of Alabama at Birmingham

Responsible Party: Alan Tita, Assoc Prof, University of Alabama at Birmingham Identifier: NCT00290199     History of Changes
Other Study ID Numbers: F051021005
First Posted: February 10, 2006    Key Record Dates
Results First Posted: October 31, 2012
Last Update Posted: May 23, 2017
Last Verified: April 2017

Keywords provided by Alan Tita, University of Alabama at Birmingham:
Fetal Membranes, Premature Rupture
Labor, Induced
Foley Catheter

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Wounds and Injuries
Obstetric Labor Complications
Pregnancy Complications