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

Phase 2

Completed

• Conditions: Pregnancy; Labor
• Interventions: Drug: DF01; Drug: Placebo

• Registration Number: NCT00710242
• Lead Sponsor: Dilafor AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-03
• Status Verified: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-18
• Last Update Posted: 2009-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 263

Inclusion Criteria

• healthy nulliparous females
• normal singleton pregnancy
• intact membranes

Exclusion Criteria

• breech or other abnormal presentation
• intercurrent illness
• pregnancy complications
• vaginal bleeding in third trimester
• etc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DF01	DF01
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes until partus in women with vaginal delivery	See above

Secondary Outcome Measures

Name	Time	Method
Complications of labor	At delivery

Trial Locations

Locations (15)

Lanssjukhuset; 🇸🇪 Kalmar, Sweden

Kvinnokliniken Alvsborgs sjukhus Boras; 🇸🇪 Boras, Sweden

Lanssjukhuset Ryhov; 🇸🇪 Jonkoping, Sweden

Kärnsjukhuset; 🇸🇪 Skövde, Sweden

Sodersjukhuset; 🇸🇪 Stockholm, Sweden

Sahlgrenska/Ostra sjukhuset; 🇸🇪 Goteborg, Sweden

Karolinska Universistetssjuhuset; 🇸🇪 Huddinge, Sweden

Universitetssjukhuset; 🇸🇪 Örebro, Sweden

Vrinnevisjukhuset; 🇸🇪 Norrköping, Sweden

Nyköpings lasarett; 🇸🇪 Nyköping, Sweden

Danderyds sjukhus; 🇸🇪 Stockholm, Sweden

Norra Älvsborgs länssjukhus; 🇸🇪 Trollhättan, Sweden

Akademiska sjukhuset; 🇸🇪 Uppsala, Sweden

Centrallasarettet; 🇸🇪 Växjö, Sweden

Gavle sjukhus; 🇸🇪 Gavle, Sweden