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OpenTrials
Completed

NCT Number: NCT00710242

Study to Assess Safety and Efficacy of DF01 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.

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Key information

Conditions

Pregnancy Labor

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Kvinnokliniken Alvsborgs sjukhus Boras, Borås, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DF01

Drug

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

Drug

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Complications of labor

    Time frame: At delivery

Sponsors and collaborators

Lead sponsor

Dilafor AB

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2008
Registry last updated
May 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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