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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix

NCTNCT04000438 (opens ClinicalTrials.gov in a new tab)Other idPPL17Other id2019-000620-17Other id2019
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Oxytocin, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 2
Enrollment
365 participants (actual)
Sponsor
Dilafor AB · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

Finland, Sweden

Start
21 Jun 2019
Primary completion
14 Feb 2023
Completion
30 Mar 2023
First posted
27 Jun 2019
Last update posted
6 May 2025
Conditions
Labor Onset and Length Abnormalities

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021202220232024
  1. Ph 2

    Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix

    NCT04000438

    21 Jun 2019 to 30 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DF01Drug
  • PL1Drug

Arms4

  • Experimental

    Experimental DF01 high dose

    The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.

  • Experimental

    Experimental: DF01 medium dose

    The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.

  • Experimental

    Experimental: DF01 low dose

    The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.

  • Placebo comparator

    Placebo comparator: PL1

    The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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).

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).

Cervical Ripening Rate, Measured by Bishop Score - Slope

GroupValue (Slope (Bishop Score/day))Spread
Experimental DF01 High Dose0.860.062
Experimental: DF01 Medium Dose0.810.062
Experimental: DF01 Low Dose0.780.061
Placebo Comparator: PL10.620.060

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Experimental DF01 High DoseThe subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. 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.0 / 916 / 9152 / 91
Experimental: DF01 Medium DoseThe subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. 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.0 / 857 / 8554 / 85
Experimental: DF01 Low DoseThe subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. 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.0 / 832 / 8354 / 83
Placebo Comparator: PL1The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor. 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/prostaglandins0 / 882 / 8847 / 88

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 64 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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 \<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 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

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