Study to Assess Safety and Efficacy of DF01 in Reducing Prolonged Labor
NCT ID: NCT00710242
Last Updated: 2009-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
263 participants
INTERVENTIONAL
2007-04-30
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix
NCT04000438
Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest
NCT03001193
Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®
NCT03665688
Dilapan-S® for Induction of Labor The Feasibility Study
NCT04521062
Clinical Evaluation of Cervical Ripening in the Outpatient Setting
NCT04271722
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
DF01
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)
2
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* normal singleton pregnancy
* intact membranes
Exclusion Criteria
* intercurrent illness
* pregnancy complications
* vaginal bleeding in third trimester
* etc
18 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dilafor AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dilafor AB
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lena Granstrom, MD
Role: PRINCIPAL_INVESTIGATOR
Kvinnokliniken Sodra Alvsborgs sjukhus Boras
Gunvor Ekman-Ordeberg, MD, PhD
Role: STUDY_CHAIR
Dilafor AB
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kvinnokliniken Alvsborgs sjukhus Boras
Borås, , Sweden
Gavle sjukhus
Gävle, , Sweden
Sahlgrenska/Ostra sjukhuset
Gothenburg, , Sweden
Karolinska Universistetssjuhuset
Huddinge, , Sweden
Lanssjukhuset Ryhov
Jönköping, , Sweden
Lanssjukhuset
Kalmar, , Sweden
Universitetssjukhuset
Linköping, , Sweden
Universitetssjukhuset
Lund, , Sweden
Vrinnevisjukhuset
Norrköping, , Sweden
Nyköpings lasarett
Nyköping, , Sweden
Universitetssjukhuset
Örebro, , Sweden
Kärnsjukhuset
Skövde, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Sodersjukhuset
Stockholm, , Sweden
Norra Älvsborgs länssjukhus
Trollhättan, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Centrallasarettet
Vaxjo, , Sweden
Centrallasarettet
Västerås, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ekman-Ordeberg G, Hellgren-Wangdahl M, Jeppson A, Rahkonen L, Blomberg M, Pettersson K, Bejlum C, Engberg M, Ludvigsen M, Uotila J, Tihtonen K, Hallberg G, Jonsson M. Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies. Am J Obstet Gynecol. 2024 Mar;230(3S):S759-S768. doi: 10.1016/j.ajog.2022.10.013. Epub 2023 May 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PPL02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.