Study to Assess Safety and Efficacy of DF01 in Reducing Prolonged Labor - Full Text View

Sponsored by:	Dilafor AB
Information provided by:	Dilafor AB
ClinicalTrials.gov Identifier:	NCT00710242

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	260
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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)
2: Placebo Comparator	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

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

Contacts

Contact: Karin Soderberg	46-8-5248-4702	karin.soderberg@dilafor.com
Contact: Anders Asell	46-8-5248-4720	anders.asell@dilafor.com

Locations

Sweden
Kvinnokliniken Alvsborgs sjukhus Boras	Recruiting
Boras, Sweden, SE-501 82
Contact: Lena Granstrom, MD 46-33-616-1000 lena.granstrom@vgregion.se
Sodersjukhuset	Recruiting
Stockholm, Sweden
Principal Investigator: Gisela Wegnelius, MD
Lanssjukhuset Ryhov	Recruiting
Jonkoping, Sweden
Principal Investigator: Roland Boij, MD
Danderyds sjukhus	Recruiting
Stockholm, Sweden
Principal Investigator: Margareta Norman, MD
Centrallasarettet	Recruiting
Vasteras, Sweden
Principal Investigator: Stellan Hogstedt, MD
Sahlgrenska/Ostra sjukhuset	Recruiting
Goteborg, Sweden
Principal Investigator: Margareta Hellgren, MD
Universitetssjukhuset	Recruiting
Linkoping, Sweden
Principal Investigator: Annika Jeppsson, MD
Karolinska Universistetssjuhuset	Recruiting
Huddinge, Sweden
Principal Investigator: Anneli Kaldma, MD
Akademiska sjukhuset	Recruiting
Uppsala, Sweden
Principal Investigator: Gunilla Hallberg, MD
Norra Älvsborgs länssjukhus	Recruiting
Trollhättan, Sweden
Principal Investigator: Mona Söderlund, MD
Lanssjukhuset	Recruiting
Kalmar, Sweden
Principal Investigator: Ann-Marie Lindstrom, MD
Universitetssjukhuset	Recruiting
Lund, Sweden
Principal Investigator: Monica Lilja, MD
Vrinnevisjukhuset	Recruiting
Norrköping, Sweden
Principal Investigator: Agneta Werner, MD
Kärnsjukhuset	Recruiting
Skövde, Sweden
Principal Investigator: Jan Leyon, MD
Nyköpings lasarett	Recruiting
Nyköping, Sweden
Principal Investigator: Margareta Pettersson, MD
Centrallasarettet	Recruiting
Växjö, Sweden
Principal Investigator: Mats Hurtig, MD
Universitetssjukhuset	Recruiting
Örebro, Sweden
Principal Investigator: Anna-Lena Bryngelsson, MD
Gavle sjukhus	Recruiting
Gavle, Sweden
Principal Investigator: Inger Blomberg, MD

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:	Dilafor AB ( Clinical Research Director )
Study ID Numbers:	PPL02
Study First Received:	July 1, 2008
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00710242 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Dilafor AB:

prolonged labor

ClinicalTrials.gov processed this record on May 07, 2009