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

Cervical Ripening Clinical Trial

— FOLEYEASI  

Official title:

Randomized Trial of Transcervical Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442663
• Other study ID #: F050629003
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: April 23, 2007
• Start date: June 2003
• Est. completion date: December 2005

Study information

• Verified date: April 2007
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Labor Induction

Intervention

Device:
• Transcervical Foley Catheter

• Transcervical Foley Catheter with an EASI

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Greenville Hospital System, University Medical Center	Greenville	South Carolina
United States	Saint Luke's Hospital	Kansas City	Kansas
United States	Truman Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (2)

Guinn DA, Davies JK, Jones RO, Sullivan L, Wolf D. Labor induction in women with an unfavorable Bishop score: randomized controlled trial of intrauterine Foley catheter with concurrent oxytocin infusion versus Foley catheter with extra-amniotic saline infusion with concurrent oxytocin infusion. Am J Obstet Gynecol. 2004 Jul;191(1):225-9. — View Citation

Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from the start of labor induction to delivery
Secondary	Secondary maternal outcomes included cesarean delivery, chorioamnionitis and endometritis. Neonatal outcomes included birthweight, Apgar scores and cord blood gas analysis