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Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction (FOLEYEASI)

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ClinicalTrials.gov Identifier: NCT00442663
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : April 24, 2007
Sponsor:
Information provided by:
University of Alabama at Birmingham

Brief Summary:
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 or disease Intervention/treatment Phase
Labor Induction Cervical Ripening Device: Transcervical Foley Catheter Device: Transcervical Foley Catheter with an EASI Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Study Start Date : June 2003
Actual Study Completion Date : December 2005



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

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


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00442663


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Kansas
Truman Medical Center
Kansas City, Kansas, United States, 64108
Saint Luke's Hospital
Kansas City, Kansas, United States, 64111
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