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

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ClinicalTrials.gov Identifier: NCT00710242
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : May 19, 2009
Sponsor:
Information provided by:
Dilafor AB

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Labor Drug: DF01 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009
Arms and Interventions
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Arm Intervention/treatment
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)
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)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Complications of labor [ Time Frame: At delivery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710242


Locations
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Sweden
Kvinnokliniken Alvsborgs sjukhus Boras
Boras, Sweden, SE-501 82
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
Kärnsjukhuset
Skövde, Sweden
Danderyds sjukhus
Stockholm, Sweden
Sodersjukhuset
Stockholm, Sweden
Norra Älvsborgs länssjukhus
Trollhättan, Sweden
Akademiska sjukhuset
Uppsala, Sweden
Centrallasarettet
Vasteras, Sweden
Centrallasarettet
Växjö, Sweden
Universitetssjukhuset
Örebro, Sweden
Sponsors and Collaborators
Dilafor AB
Investigators
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Principal Investigator: Lena Granstrom, MD Kvinnokliniken Sodra Alvsborgs sjukhus Boras
Study Chair: Gunvor Ekman-Ordeberg, MD, PhD Dilafor AB
More Information
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Responsible Party: Clinical Research Director, Dilafor AB
ClinicalTrials.gov Identifier: NCT00710242    
Other Study ID Numbers: PPL02
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: May 2009
Keywords provided by Dilafor AB:
prolonged labor