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

Cervical Ripening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366951
• Other study ID #: ORA#: 03111102
• Status: Completed
• Phase: N/A
• First received: August 18, 2006
• Last updated: December 28, 2007
• Start date: April 2004
• Est. completion date: November 2005

Study information

• Verified date: December 2007
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• singleton gestation

• cephalic vertex presentation

• intact membrane

• gestational age between 30 and 42 weeks

• Bishop score less than or equal to 5

Exclusion Criteria:

• suspected chorioamnionitis

• placenta previa

• low lying placenta

• unexplained vaginal bleeding

• intrauterine fetal demise

• HIV

• any contraindication to vaginal delivery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Labor, Induced

Intervention

Procedure:
• Foley catheter only

• Extraamniotic saline infusion

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time interval from placement of Foley catheter to vaginal delivery
Secondary	Cesarean delivery rate
Secondary	Incidence of maternal complications
Secondary	Incidence of neonatal complications