Labor Onset and Length AbnormalitiesPhase 2NCT04000438
Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix
A Phase 2 study testing DF01 and PL1 in people with Labor Onset and Length Abnormalities, run by Dilafor AB at 7 sites in 2 countries.
Trial summary
The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Onset and Length Abnormalities
- What is being tested?
- DF01 and PL1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 21 Jun 2019to 30 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women of ≥18 and ≤ 64 years of age
- Nulliparous
- Unripe cervix with ≤ 4points according to Bishop/Westin score (0-10 points scale)
- Planned for labor induction after 4-7 days of IMP treatment
- Examples of diagnosis as a basis for induction:
- Post term pregnancy (40-41 weeks of gestation)
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- Gestational diabetes
- Diabetes type 1 - well controlled
- Pre-eclampsia (BP diastolic <100, systolic <140)
- Hypertension - well controlled
- Hepatosis (without clinically significantly elevated serum bile acids)
- Maternal age ≥ 40 years
- Humanitarian-psycho social reasons
- Oligohydramnios
- Gestational age > 37 weeks confirmed by ultrasound before 21 weeks of gestation
- Singleton pregnancy
- Subject is, as per the discretion of the Investigator, able to comply with the requirements of the protocol including an ability to be present at all required controls
- Subject can understand and sign an informed form
- Provision of written informed consent
Who cannot join
- Subjects who are unable to understand the written and verbal instructions in local language
- Breech presentation and other abnormal fetal presentations
- Previous uterine scar
- Spontaneous rupture of membranes at inclusion
- Pathologic CTG at inclusion
- Fetal estimated weight > 2SD of normal fetal estimated weight earlier diagnosed by ultrasound and documented in patient record
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- Mother's BMI > 35 at early pregnancy
- Known IUGR defined as ≤ 2SD of normal
- Presence of eclampsia
- Severe Pre-eclampsia
- HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
- Clinically significant vaginal bleeding in need of hospitalization in the third trimester
- Placenta previa
- Previously known coagulation disorders (Leiden, heterozygote - OK)
- Current use of any drugs that interfere with hemostasis (including heparin /LMWH, direct oral anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAID) compounds and vitamin K antagonists.)
- Current use of acetylsalicylic acid (ASA) compounds or use within the week preceding inclusion
- Diagnosed with HIV or Acute hepatitis
- Known history of allergy to standard heparin and/or LMWH heparin
- History of heparin-induced thrombocytopenia
- Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study.
- Current participation in other interventional medicinal treatment studies
- Subject has a fear of needles which is believed by the Investigator to affect study medication compliance
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Sweden5 sites
Kvinnokliniken Universitetssjukhuset Linköping
Linköping, 581 85
Lund University Hospital
Lund
Kvinnokliniken Skaraborgs Sjukhus
Skövde, 54185
Kvinnokliniken Södersjukhuset
Stockholm, 11883
Förlossningsavdelningen Akademiska Universitetssjukhuset
Uppsala, 751 85
Finland2 sites
Naistenklinikka (HUS)
Helsinki, 00029
Tampere University Hospital
Tampere, 33521
About this study
Official title: Randomized, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy on Cervical Ripening, Safety, Tolerability and Dose Response of SC Administered Tafoxiparin in Term Pregnant, Nulliparous Women With an Unripe Cervix Undergoing Labor Induction
The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are conclusive in favor of tafoxiparin, the study will continue by adding two additional tafoxiparin dose groups in Section B.
Read the detailed description
Primary objective:
To assess the efficacy of tafoxiparin on cervical ripening.
Secondary objective:
To assess the maternal and neonatal safety, tolerability and dose response of tafoxiparin as a supplement therapy in term pregnant, nulliparous women with an unripe cervix undergoing labor induction
Methodology:
Term pregnant, nulliparous women with unripe cervix and planned for labor induction are potential study patients unless enrolled in another study. Subjects may be preinformed about the study through the use of advertisement or information at the physician/midwife visits during pregnancy and at the hospital admission.
The whole study includes the following steps:
Screening and Baseline including informed consent and randomization Study treatment and Induction of Labor Labor Discharge
- Conditions
- Labor Onset and Length Abnormalities
- Being tested
- DF01, PL1
- Keywords
- Priming of labor, Unripe cervix, Home treatment, Cervical ripening, Labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF01Drug
Also called tafoxiparin
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
PL1Drug
Also called Placebo
DF01: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
| Study group | Role | What they receive |
|---|---|---|
| Experimental DF01 high dose | Experimental | The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. Receives: Drug: DF01 |
| Experimental: DF01 medium dose | Experimental | The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. Receives: Drug: DF01 |
| Experimental: DF01 low dose | Experimental | The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. Receives: Drug: DF01 |
| Placebo comparator: PL1 | Placebo comparator | The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. Receives: Drug: PL1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Ripening Rate, Measured by Bishop Score - Slope
Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope.
Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency.
The score was calculated as the sum of the following 5 categories where each category is scored between 0-2:
- Fetal station (0-2)
- Cervical diameter at inner meatus (0-2)
- Cervical effacement (0-2)
- Consistency at inner meatus (0-2)
- Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe.
Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.
Measured: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start21 Jun 2019
- Primary completion14 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Labor Onset and Length AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilafor AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunvor Ekman-Ordeberg, MD, PhD, Study Chair, CMO, Study chair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000438
- Sponsor's protocol ID
- PPL17
- Other IDs
- 2019-000620-17, 2019
- Status last verified
- Mar 2025
- First submitted
- 14 Jun 2019
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy on Cervical Ripening, Safety, Tolerability and Dose Response of SC Administered Tafoxiparin in Term Pregnant, Nulliparous Women With an Unripe Cervix Undergoing Labor Induction
- ClinicalTrials.gov ID
- NCT04000438
- Acronym / sponsor ID
- PPL17
- Conditions
- Labor Onset and Length Abnormalities
- Keywords
- Priming of labor, Unripe cervix, Home treatment, Cervical ripening, Labor induction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Dilafor ABIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are conclusive in favor of tafoxiparin, the study will continue by adding two additional tafoxiparin dose groups in Section B.
Detailed description
Primary objective:
To assess the efficacy of tafoxiparin on cervical ripening.
Secondary objective:
To assess the maternal and neonatal safety, tolerability and dose response of tafoxiparin as a supplement therapy in term pregnant, nulliparous women with an unripe cervix undergoing labor induction
Methodology:
Term pregnant, nulliparous women with unripe cervix and planned for labor induction are potential study patients unless enrolled in another study. Subjects may be preinformed about the study through the use of advertisement or information at the physician/midwife visits during pregnancy and at the hospital admission.
The whole study includes the following steps:
Screening and Baseline including informed consent and randomization Study treatment and Induction of Labor Labor Discharge
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental DF01 high dose | Experimental | Drug: DF01The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. |
| Experimental: DF01 medium dose | Experimental | Drug: DF01The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. |
| Experimental: DF01 low dose | Experimental | Drug: DF01The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. |
| Placebo comparator: PL1 | Placebo comparator | Drug: PL1The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Pregnant women of ≥18 and ≤ 64 years of age
- Nulliparous
- Unripe cervix with ≤ 4points according to Bishop/Westin score (0-10 points scale)
- Planned for labor induction after 4-7 days of IMP treatment
- Examples of diagnosis as a basis for induction:
Key exclusion criteria (22 listed)
- Subjects who are unable to understand the written and verbal instructions in local language
- Breech presentation and other abnormal fetal presentations
- Previous uterine scar
- Spontaneous rupture of membranes at inclusion
- Pathologic CTG at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DF01Also: tafoxiparinDF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins | Drug | Experimental DF01 high dose, Experimental: DF01 low dose, Experimental: DF01 medium dose |
| PL1Also: PlaceboDF01: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins | Drug | Placebo comparator: PL1 |
Primary outcome
Cervical Ripening Rate, Measured by Bishop Score - Slope
Time frame: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).
Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope. Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency. The score was calculated as the sum of the following 5 categories where each category is scored between 0-2: * Fetal station (0-2) * Cervical diameter at inner meatus (0-2) * Cervical effacement (0-2) * Consistency at inner meatus (0-2) * Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe. Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Labor Onset and Length Abnormalities
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunvor Ekman-Ordeberg, MD, PhD, Study Chair, CMO study chair
CMO
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DF01 and PL1 in people with Labor Onset and Length Abnormalities, run by Dilafor AB at 7 sites in 2 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 19 inclusion and 22 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 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Finland. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cervical Ripening Rate, Measured by Bishop Score - Slope (time frame: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.