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

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ClinicalTrials.gov Identifier: NCT04000438
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Dilafor AB

Brief 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.

Condition or disease Intervention/treatment Phase
Labor Onset and Length Abnormalities Drug: DF01 Drug: PL1 Phase 2

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 stuyd 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
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.
Drug: DF01
The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1
Other Name: tafoxiparin

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.
Drug: DF01
The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1
Other Name: tafoxiparin

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.
Drug: DF01
The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1
Other Name: tafoxiparin

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.
Drug: PL1
The subject receives sc injections once daily of placebo solution for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1
Other Name: Placebo




Primary Outcome Measures :
  1. Rate of cervical ripening [ Time Frame: From start of study drug administration to cervical ripening (up to 7 days) ]
    Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score


Secondary Outcome Measures :
  1. Time to start of treatment in relation to cervical ripening ≥ 2 points [ Time Frame: From start of study drug administration to cervical ripening (up to 7 days) ]
    Time from start of treatment to increase in Bishop score of ≥ 2 points or spontaneous onset of labor, whichever comes first

  2. Time to start of treatment in relation to cervical ripening ≥ 3 points [ Time Frame: From start of study drug administration to cervical ripening (up to 7 days) ]
    Time from start of treatment to increase in Bishop score of ≥ 3 points or spontaneous onset of labor, whichever comes first

  3. Time to start of treatment in relation to cervical ripening ≥ 4 points [ Time Frame: From start of study drug administration to cervical ripening (up to 7 days) ]
    Time from start of treatment to increase in Bishop score of ≥ 4 points or spontaneous onset of labor, whichever comes first

  4. Time to partus from labor onset [ Time Frame: Interval from 4 cm of cervical dilatation until delivery (hours up to 36 hours) ]
    Time from onset of labor to partus. Onset of labor is defined as last record of 4 cm cervical dilatation visualized in the partogram and progress of labor or last record of 4 cm of cervical dilatation in combination with amniotomy and intravenous administration oxytocin

  5. Time of labor ≤ 6 hours [ Time Frame: Interval from 4 cm of cervical dilatation until delivery (hours up to 36 hours) ]
    Proportion of women with established labor ≤ 6 hours

  6. Time of labor ≥ 12 hours [ Time Frame: Interval from 4 cm of cervical dilatation until delivery (hours up to 36 hours) ]
    Proportion of women with established labor ≥ 12 hours

  7. Dosages of study drug [ Time Frame: From start of study drug administration to cervical ripening (up to 7 days) ]
    Total dosages of study drug (IMP)

  8. Secondary Safety and tolerability endpoint - adverse event and serious adverse event [ Time Frame: Through study completion (up to 3 days after delivery) ]
    Safety and tolerability will be evaluated through rate and frequency of adverse events and serious adverse events. The AE and SAE will be coded using MedDRA version 19.1.

  9. Secondary Safety and tolerability endpoint- caesarean sections [ Time Frame: From start of study drug administration until delivery (up to 7 days) ]
    Proportion of patients undergoing caesarean sections (CS)

  10. Secondary Safety and tolerability endpoint- indications for caesarean sections [ Time Frame: From start of study drug administration until delivery (up to 7 days) ]
    Indications for CS

  11. Secondary Safety and tolerability endpoint -instrumental deliveries [ Time Frame: From start of study drug administration until delivery (up to 7 days) ]
    Proportion of patients undergoing instrumental deliveries (vacuum extraction (VE)/forceps delivery)

  12. Secondary Safety and tolerability endpoint- VE and forceps deliveries [ Time Frame: From start of study drug administration until delivery (up to 7 days) ]
    Indications for VE and forceps deliveries

  13. Secondary Safety and tolerability endpoint- fetal outcome- Birth weight [ Time Frame: From start of study drug administration until delivery ( up to 7 days) ]
    Fetal outcome measured as Birth weight (kg)

  14. Secondary Safety and tolerability endpoint- fetal outcome -Apgar score [ Time Frame: From start of study drug administration until delivery ( up to 7 days) ]
    Fetal outcome measured as Apgar score (1-10 points). A score > 7 is good health.

  15. Secondary Safety and tolerability endpoint- fetal outcome - Acidosis and/or Base excess [ Time Frame: From start of study drug administration until delivery ( up to 7 days) ]
    Fetal outcome measured as number of neonatal with Acidosis (pH<7.10) and/or Base Excess < -12 mmol/L arterial or venous in umbilical cord blood

  16. Secondary Safety and tolerability endpoint - NICU [ Time Frame: From start of study drug administration until delivery (days) ]
    Indication for referral to neonatal intensive care unit (NICU)

  17. Secondary Safety and tolerability endpoint - NICU [ Time Frame: From start of study drug administration until delivery (up to 7 days) ]
    Proportion of infants staying in the NICU for > 48 hours

  18. Secondary Safety and tolerability endpoint - tocolytica [ Time Frame: From start of study drug administration until delivery (up to 7 days) ]
    Uterine hyper stimulation in demand of tocolytic treatment

  19. Secondary Safety and tolerability endpoint - PPH [ Time Frame: From start of study drug administration until delivery (up to 7 days) ]
    Proportion of patients with Postpartum Hemorrhage (PPH) > 2000 ml



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000438


Contacts
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Contact: Lena Degling Wikingsson, PhD +46(0)707900207 lena.wikingsson@dilafor.com
Contact: Gunvor Ekman -Ordeberg, MD, PhD +46 (0)70 608 3111 Gunvor.ekman-ordeberg@dilafor.com

Locations
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Finland
Naistenklinikka (HUS) Recruiting
Helsinki, Finland, 00029
Sweden
Kvinnokliniken Universitetssjukhuset Linköping Recruiting
Linköping, Sweden, 581 85
Förlossningsavdelningen Akademiska Universitetssjukhuset Recruiting
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Dilafor AB
Investigators
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Study Chair: Gunvor Ekman-Ordeberg, M,mPhD CMO

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Responsible Party: Dilafor AB
ClinicalTrials.gov Identifier: NCT04000438     History of Changes
Other Study ID Numbers: PPL17
2019-000620-17 ( EudraCT Number )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilafor AB:
labor induction
cervical ripening
Additional relevant MeSH terms:
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Congenital Abnormalities