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Labor, ObstetricPhase 2NCT03001193

Effect of Tafoxiparin to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest

A Phase 2 study testing DF 01 and Oxytocin in people with Labor, Obstetric, run by Dilafor AB at 12 sites in 3 countries.

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 will be designed as a double-blind, placebo-controlled, parallel-group, dose-finding study with one group treated with placebo and three groups treated with tafoxiparin in three different infusion concentration levels, respectively. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor, Obstetric
What is being tested?
DF 01 and Oxytocin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
361 participants
Where
12 sitesin 3 countries
Study dates
Dec 2016to May 2019
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant women of ≥18 to ≤45 years of age
  • Nulliparous
  • Gestational age > 36 weeks + 6 days confirmed by ultrasound
  • Experience slow progress of labor including prolonged latent phase and labor arrest (according to the respective definitions) etc

Who cannot join

  • Subjects with secondary slow progress or secondary labor arrest
  • BMI≥35 during first trimester of pregnancy
  • Breech presentation or other abnormal presentations etc

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

Sweden8 sites

  • Helsingborg Förlossningen, Helsingborgs Lasarett

    Helsingborg, 25187

  • Länssjukhuset Ryhov

    Jönköping, 55305

  • Karlstad Kvinnokliniken Centralsjukhuset

    Karlstad, 65230

  • Kvinnokliniken Universitesjukhuset

    Linköping, 58185

  • Kvinnokliniken Vrinnevisjukhuset

    Norrköping, 60182

  • Skaraborgs sjukhus

    Skövde, 54185

  • Norra Älvsborgs Länssjukhus

    Trollhättan, 46173

  • Akademiska sjukhuset

    Uppsala, 75185

Other trials in Sweden

Finland3 sites

  • Naistenklinikka (HUS) Naistentaudit ja synnytykset

    Helsinki, 00029

  • Kätilöopiston Sairaala (HUS)

    Helsinki, 00610

  • Tampere University Hospital

    Tampere, 33521

Other trials in Finland

Denmark1 site

  • Hvidovre Hospital, Fødeafdelingen

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Effect of Continuous Infusion of Tafoxiparin as an Adjunct Treatment to Oxytocin for up to 36 Hours in Term Pregnant, Nulliparous Women to Treat Primary Slow Progress of Labor Including Prolonged Latent Phase and Labor Arrest

The study will be designed as a double-blind, placebo-controlled, parallel-group, dose-finding study with one group treated with placebo and three groups treated with tafoxiparin in three different infusion concentration levels, respectively. The intravenous infusion will be initiated by a pre-defined bolus dose infusion.

Read the detailed description

Primary objective

To assess the dose-response relationship of tafoxiparin on the labor time defined as the time from the start of continuous infusion of tafoxiparin/placebo as an Adjunct Treatment to Oxytocin, until partus in term-pregnant, nulliparous women requiring labor augmentation due to Primary Slow Progress of Labor including prolonged latent phase and Labor Arrest.

Secondary objectives

To assess the safety and efficacy of tafoxiparin based on the safety and secondary efficacy parameters evaluated in the protocol. PK (pharmacokinetic) response in pregnant women during labor.

Methodology

All term-pregnant, nulliparous women presenting to the delivery ward are potential study patients unless they have already been enrolled in another clinical study. Subjects may be pre-informed about the study through the use of advertisements or information at the physician/midwife visits during pregnancy and at hospital admission.

The whole study includes the following steps:

  • Screening and Baseline including informed consent and randomization
  • Labor
  • Discharge
  • Follow-up at 8 (+/-1)weeks - End of study
  • Safety follow up of infant at 6 months, +/-4 weeks, by telephone interview
Being tested
DF 01, Oxytocin, Placebo
Keywords
Primary slow progress, Prolonged latent phase, Labor arrest

What participants receive

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

  • DF 01Drug

    Also called Tafoxiparin

  • OxytocinDrug

  • PlaceboDrug

    Also called PL1

Study groups in NCT03001193
Study groupRoleWhat they receive
DF01 low doseExperimentalThe subjects will receive intravenous infusion of DF01 (tafoxiparin) in low dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
Receives: Drug: DF 01; Drug: Oxytocin
DF01 medium doseExperimentalThe subjects will receive intravenous infusion of DF01 (tafoxiparin) in medium dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
Receives: Drug: DF 01; Drug: Oxytocin
DF01 high doseExperimentalThe subjects will receive intravenous infusion of DF01 (tafoxiparin) in high dose as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
Receives: Drug: DF 01; Drug: Oxytocin
PL1Placebo comparatorThe subjects will receive intravenous infusion of placebo as an Adjunct Treatment to Oxytocin for up to 36 hours initiated by a pre-defined bolus dose as a therapeutic intervention until delivery
Receives: Drug: Oxytocin; Drug: Placebo

What is being measured

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

  1. Time from start of infusion of tafoxiparin/placebo until vaginal partus

    The primary endpoint (time from first infusion to vaginal partus) will be summarized graphically for each treatment group using Kaplan-Meier estimates. In addition to this statistical comparison between the treatments will be performed using the analysis of variance technique.

    Measured: Interval from start of study drug administration to vaginal delivery (hours, up to 36 hours )

Secondary outcomes (13)

  1. Safety will be evaluated through rate and frequency of adverse events and serious adverse events

    Safety will be evaluated through rate and frequency of adverse events and serious adverse events, complete and symptom-directed physical evaluations, vital signs, safety blood samples (hematology and clinical chemistry), and rate of withdrawals from the study and/or the study medication

    Measured: Through study completion ( 6 months, +/-4 weeks after delivery)

  2. Time from cervical dilatation of 4 cm and progress of labor until vaginal partus

    Measured: Interval from 4 cm of cervical dilatation to vaginal delivery (hours, up to 36 hours )

  3. Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours of established labor (4 cm of cervical dilation to vaginal partus )

    Measured: Interval from 4 cm of cervical dilatation to vaginal delivery (hours, up to 36 hours )

  4. Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours from start of study drug infusion to vaginal partus

    Measured: Interval from start of study drug administration to vaginal delivery (hours, up to 36 hours )

  5. Proportion of women with caesarean sections

    Measured: From start of study drug administration to caesarean section (hours, up to 36 hours)

  6. Proportion of women undergoing instrumental deliveries

    Measured: From start of study drug administration to instrumental delivery (hours, up to 36 hours)

  7. Use of analgesia (N2O, epidural, pudendal nerve block)

    Measured: From start of study drug administration to any delivery (hours, up to 36 hours)

  8. Proportion of women with postpartum hemorrhage > 1000 ml

    Measured: From start of study drug administration and up to 7 days or discharge whichever comes first (days)

  9. Fetal outcome measured as Apgar score (5 min) ≤ 7 points, Base Excess > -12 and referral to NICU (neonatal intensive care unit) (for > 48 hours

    Measured: From start of study drug administration and up to 7 days or discharge whichever comes first (days)

  10. Uterine hyperstimulation with fetal heart rate changes

    Measured: From start of study drug administration to any delivery (hours, up to 36 hours)

  11. Indication for referral to NICU

    Measured: From start of study drug administration through study completion (6 months +- 4 weeks after delivery)

  12. Use of Oxytocin (no. of mls. according to instructions)

    Measured: From start of study drug administration to any delivery (hours, up to 36 hours)

  13. Pharmacokinetic response

    Measurement of study drug in plasma at one time point

    Measured: From start of study drug administration to any delivery (hours, up to 36 hours)

Timeline

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

  1. First posted22 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionNov 2018
  4. Study completionMay 2019

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
361 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03001193
Sponsor's protocol ID
PPL07
Status last verified
Apr 2020
First submitted
6 Dec 2016
Last updated
29 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
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 DF 01 and Oxytocin in people with Labor, Obstetric, run by Dilafor AB at 12 sites in 3 countries.

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 4 inclusion and 3 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Sweden, Finland, Denmark. 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 start of infusion of tafoxiparin/placebo until vaginal partus (time frame: Interval from start of study drug administration to vaginal delivery (hours, up to 36 hours )). 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 NCT03001193, 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 29 Apr 2020.

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