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

This study has been completed.
Sponsor:
Information provided by:
Dilafor AB
ClinicalTrials.gov Identifier:
NCT00710242
First received: July 1, 2008
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Pregnancy
Labor
Drug: DF01
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Dilafor AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications of labor [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710242

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

No publications provided

Responsible Party: Clinical Research Director, Dilafor AB
ClinicalTrials.gov Identifier: NCT00710242     History of Changes
Other Study ID Numbers: PPL02
Study First Received: July 1, 2008
Last Updated: May 18, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by Dilafor AB:
prolonged labor

ClinicalTrials.gov processed this record on August 21, 2014