NCT00710242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for phase_2 pregnancy

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 19, 2009

Status Verified

May 1, 2009

Enrollment Period

1.9 years

First QC Date

July 1, 2008

Last Update Submit

May 18, 2009

Conditions

PregnancyLabor

Keywords

prolonged labor

Outcome Measures

Primary Outcomes (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

    See above

Secondary Outcomes (1)

  • Complications of labor

    At delivery

Study Arms (2)

1

EXPERIMENTAL

DF01

Drug: DF01

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DF01DRUG

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)

1
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy nulliparous females
  • normal singleton pregnancy
  • intact membranes

You may not qualify if:

  • breech or other abnormal presentation
  • intercurrent illness
  • pregnancy complications
  • vaginal bleeding in third trimester
  • etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Kvinnokliniken Alvsborgs sjukhus Boras

Borås, SE-501 82, Sweden

Location

Gavle sjukhus

Gävle, Sweden

Location

Sahlgrenska/Ostra sjukhuset

Gothenburg, Sweden

Location

Karolinska Universistetssjuhuset

Huddinge, Sweden

Location

Lanssjukhuset Ryhov

Jönköping, Sweden

Location

Lanssjukhuset

Kalmar, Sweden

Location

Universitetssjukhuset

Linköping, Sweden

Location

Universitetssjukhuset

Lund, Sweden

Location

Vrinnevisjukhuset

Norrköping, Sweden

Location

Nyköpings lasarett

Nyköping, Sweden

Location

Universitetssjukhuset

Örebro, Sweden

Location

Kärnsjukhuset

Skövde, Sweden

Location

Danderyds sjukhus

Stockholm, Sweden

Location

Sodersjukhuset

Stockholm, Sweden

Location

Norra Älvsborgs länssjukhus

Trollhättan, Sweden

Location

Akademiska sjukhuset

Uppsala, Sweden

Location

Centrallasarettet

Vaxjo, Sweden

Location

Centrallasarettet

Västerås, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 38462256DERIVED

Study Officials

  • Lena Granstrom, MD

    Kvinnokliniken Sodra Alvsborgs sjukhus Boras

    PRINCIPAL INVESTIGATOR

  • Gunvor Ekman-Ordeberg, MD, PhD

    Dilafor AB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 4, 2008

Study Start

April 1, 2007

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

May 19, 2009

Record last verified: 2009-05

Locations

SE(18)