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
• 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

• Labor
• Pregnancy

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