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Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction (FOLEYEASI)
This study has been completed.
Sponsored by: University of Alabama at Birmingham
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00442663
  Purpose

The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.


Condition Intervention
Labor Induction
Cervical Ripening
Device: Transcervical Foley Catheter
Device: Transcervical Foley Catheter with an EASI

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction

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

Primary Outcome Measures:
  • Time from the start of labor induction to delivery

Secondary Outcome Measures:
  • Secondary maternal outcomes included cesarean delivery, chorioamnionitis and endometritis. Neonatal outcomes included birthweight, Apgar scores and cord blood gas analysis

Estimated Enrollment: 170
Study Start Date: June 2003
Study Completion Date: December 2005
Detailed Description:

In the United States, labor inductions have increased from 11% of all pregnancies in 1989 to 21% in 2004. Although the indications for labor induction vary, labor inductions as an obstetrical practice are associated with an increased risk of Cesarean delivery. As such, the rise in labor inductions has been paralleled by a rise in the cesarean rate to an all time high of 30%. The risk of cesarean can be mitigated with the use of cervical ripening agents in the setting of an unfavorable cervix. Both pharmacological ripening agents and mechanical methods are currently available for cervical priming. Methods available for mechanical dilation include, but are not limited to transcervical foley catheter alone and transcervical foley catheter with an extra-amniotic saline infusion or EASI. The potential advantage of EASI to transcervical foley catheter alone is the promotion of endogenous prostaglandin release by membrane stripping and supplying additional mechanical force. It may be disadvantageous by increasing the risk of chorioamnionitis or by diluting the prostaglandins that are released by membrane stripping. There have been two randomized trials comparing foley alone to foley with EASI. Because the results of these two trials are conflicting, we chose to conduct a randomized clinical trial of foley catheter compared to foley catheter with an EASI for labor induction and cervical ripening in women with an unfavorable cervix.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • 24-42 weeks of gestation
  • Cephalic presentation
  • Intact membranes
  • Bishop score of less than or equal to 6

Exclusion Criteria:

  • Contraindications to labor
  • Dead or severely anomalous fetus
  • Spontaneous labor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442663

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Kansas
Saint Luke's Hospital
Kansas City, Kansas, United States, 64111
Truman Medical Center
Kansas City, Kansas, United States, 64108
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: George Lu, MD Obstetrix Medical Group of Kansas City
Principal Investigator: Patrick S Ramsey, MD, MSPH University of Alabama at Birmingham
  More Information

Publications:
Publications indexed to this study:
Study ID Numbers: F050629003
Study First Received: February 28, 2007
Last Updated: April 23, 2007
ClinicalTrials.gov Identifier: NCT00442663  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Labor Induction
Cervical Ripening
Foley Catheter

ClinicalTrials.gov processed this record on January 16, 2009