Phase 2
N=348
Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix
Labor Onset and Length Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT04000438 ↗Enrolled (actual)
348
Serious AEs
4.9%
Results posted
Apr 2025
Primary outcome: Primary: Cervical Ripening Rate, Measured by Bishop Score - Slope — 0.86; 0.81; 0.78; 0.62 Slope (Bishop Score/day)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DF01 (Drug); PL1 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dilafor AB
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cervical Ripening Rate, Measured by Bishop Score - Slope |
0.86; 0.81; 0.78; 0.62 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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)
- Gestational diabetes
- Diabetes type 1 - well controlled
- Pre-eclampsia (BP diastolic 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04000438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.