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

Western Galilee Hospital-Nahariya

Status: Completed

Conditions: Cesarean; Endometritis; Induction of Labor

Treatments: Device: Mechanical induction of labor; Device: Double Balloon; Device: Foley Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00501033

4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Term pregnancy
• Parturients candidates for mechanical induction of labor

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)