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

This study has been terminated.
(Gathering information from the PI records to provide this response.)
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00290199
First received: February 9, 2006
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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 Intervention
Fetal Membranes, Premature Rupture
Labor, Induced/IS
Device: Transcervical Foley catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Hours From Placement of Foley or Initiation of Oxytocin to Delivery (up to 24 Hours) [ Time Frame: Time from induction to delivery ] [ Designated as safety issue: No ]
    The outcome measure is the mean in hours of the time from induction to delivery


Secondary Outcome Measures:
  • Rate of Delivery (Vaginal or Cesarean)by 24 Hours [ Time Frame: from start of induction to 24 hours post start of induction ] [ Designated as safety issue: Yes ]
    The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.

  • Cesarean Rate [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.

  • Induction to Vaginal Delivery Interval [ Time Frame: time from induction to vaginal delivery, up to 24 hours ] [ Designated as safety issue: No ]
    Mean hours from time of induction to vaginal delivery interval.


Enrollment: 169
Study Start Date: December 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcervical Foley Device: Transcervical Foley catheter
Foley catheter placed through cervix for cervical ripening
No Intervention: No Foley

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.

  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290199

Locations
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
Investigators
Principal Investigator: Monique G Lin, MD University of Alabama at Birmingham
Principal Investigator: Patrick S Ramsey, MD, MSPH University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00290199     History of Changes
Other Study ID Numbers: F051021005
Study First Received: February 9, 2006
Results First Received: June 1, 2012
Last Updated: September 29, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014