NCT00501033

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Induction of Labor
• Cesarean
• Endometritis

Interventions

Type	Name	Description
DEVICE	Mechanical induction of labor
DEVICE	Double Balloon
DEVICE	Foley Catheter

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-02-01
• Completion: 2008-05-01
• First posted: 2007-07-13
• Last updated: 2008-05-08

Locations

1 site across 1 country: Israel