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

May 18, 2009 updated by: Dilafor AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Boras, Sweden, SE-501 82
        • Kvinnokliniken Alvsborgs sjukhus Boras
      • Gavle, Sweden
        • Gavle Sjukhus
      • Goteborg, Sweden
        • Sahlgrenska/Ostra sjukhuset
      • Huddinge, Sweden
        • Karolinska Universistetssjuhuset
      • Jonkoping, Sweden
        • Länssjukhuset Ryhov
      • Kalmar, Sweden
        • Länssjukhuset
      • Linkoping, Sweden
        • Universitetssjukhuset
      • Lund, Sweden
        • Universitetssjukhuset
      • Norrköping, Sweden
        • Vrinnevisjukhuset
      • Nyköping, Sweden
        • Nyköpings lasarett
      • Skövde, Sweden
        • Kärnsjukhuset
      • Stockholm, Sweden
        • Danderyds Sjukhus
      • Stockholm, Sweden
        • Södersjukhuset
      • Trollhättan, Sweden
        • Norra Älvsborgs Länssjukhus
      • Uppsala, Sweden
        • Akademiska sjukhuset
      • Vasteras, Sweden
        • Centrallasarettet
      • Växjö, Sweden
        • Centrallasarettet
      • Örebro, Sweden
        • Universitetssjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
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)
Experimental: 1
DF01
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: See above
See above

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications of labor
Time Frame: At delivery
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dilafor AB

Investigators

  • Study Chair: Gunvor Ekman-Ordeberg, MD, PhD, Dilafor AB
  • Principal Investigator: Lena Granstrom, MD, Kvinnokliniken Sodra Alvsborgs sjukhus Boras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2009

Last Update Submitted That Met QC Criteria

May 18, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PPL02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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