NCT00710242

Study to Assess Safety and Efficacy of DF01 in Reducing Prolonged Labor

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Assess the Safety and Efficacy or Pre-Treatment With DF01 During Late Pregnancy in Reducing Prolonged Labor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Dilafor AB · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time to delivery will be measured from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes.

Conditions

• Pregnancy
• Labor

Interventions

Type	Name	Description
DRUG	DF01	Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery)
DRUG	Placebo	Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery)

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2008-07-04
• Last updated: 2009-05-19

Locations

18 sites across 1 country: Sweden