NCT01866488

The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor

The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor: A Double-Blinded, Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity. The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.

Conditions

• Labor Induction

Interventions

Type	Name	Description
DRUG	Misoprostol
OTHER	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-05-31
• Last updated: 2016-08-30

Locations

1 site across 1 country: United States