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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Labor | Drug: DF01 Drug: Placebo | Phase 2 |
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 |
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) |
- 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 ]
- Complications of labor [ Time Frame: At delivery ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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