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

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00366951
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Ripening; Labor, Induced	Procedure: Foley catheter only; Procedure: Extraamniotic saline infusion	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2004
• Actual Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. The time interval from placement of Foley catheter to vaginal delivery []

Secondary Outcome Measures

1. Cesarean delivery rate []

2. Incidence of maternal complications []

3. Incidence of neonatal complications []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center

Investigators

• Principal Investigator: Yukmei R Lam, MD, Rush University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00366951
• Other Study ID Numbers: ORA#: 03111102
• First Posted: Aug 22, 2006
• Last Update Posted: Jan 10, 2008
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Cervical Ripening; Labor, Induced; Balloon Dilation; Oxytocin

Study Results

No Results Posted as of Jan 10, 2008