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NCT00710242 Clinical Trial

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

Pregnancy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00710242
Other study ID # PPL02
Secondary ID
Status Completed
Phase Phase 2
First received July 1, 2008
Last updated May 18, 2009
Start date April 2007
Est. completion date May 2009

Study information
Verified date May 2009
Source Dilafor AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 263
Est. completion date May 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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)
• 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)

Locations
Country Name City State
Sweden 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 Linkoping
Sweden Universitetssjukhuset Lund
Sweden Vrinnevisjukhuset Norrköping
Sweden Nyköpings lasarett Nyköping
Sweden Universitetssjukhuset Örebro
Sweden Kärnsjukhuset Skövde
Sweden Danderyds sjukhus Stockholm
Sweden Sodersjukhuset Stockholm
Sweden Norra Älvsborgs länssjukhus Trollhättan
Sweden Akademiska sjukhuset Uppsala
Sweden Centrallasarettet Vasteras
Sweden Centrallasarettet Växjö

Sponsors (1)
Lead Sponsor Collaborator
Dilafor AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Complications of labor At delivery No
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