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PregnancyPhase 2NCT00710242

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

A Phase 2 study testing DF01 in people with Pregnancy and Labor, run by Dilafor AB at 18 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Pregnancy, Labor
What is being tested?
DF01
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
263 participants
Where
18 sitesSweden
Study dates
Apr 2007to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • healthy nulliparous females
  • normal singleton pregnancy
  • intact membranes

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Sweden18 sites

  • Kvinnokliniken Alvsborgs sjukhus Boras

    Borås, SE-501 82

  • Gavle sjukhus

    Gävle

  • Sahlgrenska/Ostra sjukhuset

    Gothenburg

  • Karolinska Universistetssjuhuset

    Huddinge

  • Lanssjukhuset Ryhov

    Jönköping

  • Lanssjukhuset

    Kalmar

  • Universitetssjukhuset

    Linköping

  • Universitetssjukhuset

    Lund

  • Vrinnevisjukhuset

    Norrköping

  • Nyköpings lasarett

    Nyköping

  • Universitetssjukhuset

    Örebro

  • Kärnsjukhuset

    Skövde

  • Danderyds sjukhus

    Stockholm

  • Sodersjukhuset

    Stockholm

  • Norra Älvsborgs länssjukhus

    Trollhättan

  • Akademiska sjukhuset

    Uppsala

  • Centrallasarettet

    Västerås

  • Centrallasarettet

    Vaxjo

Other trials in Sweden

About this 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

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.

Conditions
Pregnancy, Labor
Being tested
DF01, Placebo
Keywords
prolonged labor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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)

Study groups in NCT00710242
Study groupRoleWhat they receive
1ExperimentalDF01
Receives: Drug: DF01
2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: See above

Secondary outcomes (1)

  1. Complications of labor

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2008 (estimated)
  2. Study startApr 2007
  3. Primary completionMar 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00710242
Sponsor's protocol ID
PPL02
Status last verified
May 2009
First submitted
1 Jul 2008
Last updated
19 May 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38462256

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DF01 in people with Pregnancy and Labor, run by Dilafor AB at 18 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00710242, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2009.

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