Study to Assess Safety and Efficacy of DF01 in Reducing Prolonged Labor
- 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
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)
Kvinnokliniken Alvsborgs sjukhus Boras
🇸🇪Boras, Sweden
Gavle sjukhus
🇸🇪Gavle, Sweden
Sahlgrenska/Ostra sjukhuset
🇸🇪Goteborg, Sweden
Karolinska Universistetssjuhuset
🇸🇪Huddinge, Sweden
Lanssjukhuset Ryhov
🇸🇪Jonkoping, Sweden
Lanssjukhuset
🇸🇪Kalmar, Sweden
Universitetssjukhuset
🇸🇪Örebro, Sweden
Vrinnevisjukhuset
🇸🇪Norrköping, Sweden
Nyköpings lasarett
🇸🇪Nyköping, Sweden
Kärnsjukhuset
🇸🇪Skövde, Sweden
Scroll for more (5 remaining)Kvinnokliniken Alvsborgs sjukhus Boras🇸🇪Boras, Sweden