NCT00366951

A Randomized Study on Comparing the Efficacy of Foley Catheter and Extraamniotic Saline Infusion for Labor Induction

A Randomized Clinical Trial Comparing the Efficacy and Safety of Foley Catheter Balloon With Oxytocin and Extraamniotic Saline Infusion (EASI) With Oxytocin for Induction of Labor Requiring Cervical Ripening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Our purpose was to compare the efficacy and safety of Foley catheter with oxytocin and extraamniotic saline infusion with oxytocin for induction of labor requiring cervical ripening.

Detailed description

Induction of labor is indicated when the benefit to either the mother or fetus outweighs that of continuing the pregnancy. Labor induction in the presence of an unripened cervix is associated with prolonged labor, chorioamnionitis, and cesarean delivery. Numerous mechanical and pharmacological methods have been used for cervical ripening. There are limited numbers of rigorous studies comparing the efficacy of the various methods. One of the most common mechanical methods for cervical ripening is placement of a Foley catheter with a 30 cc balloon inside the cervix, with or without the use of oxytocin. The Foley balloon will disrupt the amniotic membrane surface and cause the release of prostaglandin, a natural chemical from the cervix, to facilitate the ripening process. Oxytocin will be used concurrently as the induction agent. Recently, a modification of this method, extraamniotic saline infusion (EASI) has become more popular. The EASI method involves similar procedure including the placement of Foley catheter inside the cervix; in addition, saline solution will be infused through the catheter. This additional step is thought to further facilitate the disruption of amniotic membrane surface. Both methods are safe and become the standard treatment for cervical ripening. However, there are no published trials so far comparing the two methods. The objective of this study is to compare the efficacy and safety of Foley catheter with oxytocin and EASI with oxytocin for induction of labor requiring cervical ripening. The study is designed to be a single masked randomized trial.

Conditions

• Cervical Ripening
• Labor, Induced

Interventions

Type	Name	Description
PROCEDURE	Foley catheter only
PROCEDURE	Extraamniotic saline infusion

Timeline

• Start date: 2004-04-01
• Completion: 2005-11-01
• First posted: 2006-08-22
• Last updated: 2008-01-10

Locations

1 site across 1 country: United States