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

NCT00710242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2009-05-19

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Labor

Interventions

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)

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)

Sponsors & Collaborators

  • Dilafor AB

    lead INDUSTRY

Principal Investigators

  • Lena Granstrom, MD · Kvinnokliniken Sodra Alvsborgs sjukhus Boras

  • Gunvor Ekman-Ordeberg, MD, PhD · Dilafor AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-03-31
Completion
2009-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00710242 on ClinicalTrials.gov