A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

Not Applicable

Completed

• Conditions: Endometritis; Induction of Labor; Cesarean

• Registration Number: NCT00501033
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

Detailed Description

We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-13
• Primary Completion: 2008-02
• Status Verified: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-02
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Term pregnancy
• Parturients candidates for mechanical induction of labor

Exclusion Criteria

• Suspected amnionitis
• Vaginal discharge
• Pre induction pyrexia
• Immunocompromised parturients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success of labor induction	Postpartum period

Secondary Outcome Measures

Name	Time	Method
Cesarean section rate	Delivery
Postpartum endometritis rate	The postpartum period

Trial Locations

Locations (1)

Western Galilee Hospital; 🇮🇱 Nahariya, Israel