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IUGR: Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01390051
Collaborator
Aarhus University Hospital (Other), LEO Pharma (Industry)
50
Enrollment
3
Locations
2
Arms
60
Duration (Months)
16.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Clinical purpose:
  1. To examine whether treatment with low molecular weight heparin in pregnant women with Intrauterine Growth Restriction (IUGR)increases the birth weight of the child. Our hypothesis is that an increased birth weight leads to reduced morbidity and mortality among these children.
Laboratory purposes:

  1. To evaluate three new methods to monitor the effect of LMWH.

  2. To investigate if 2 biochemical markers are positive predictors of IUGR IUGR is defined as a foetus that grows less than expected. IUGR is estimated to occur in up to 5% of all pregnancies, and IUGR is the second most common cause of perinatal morbidity and mortality. Thus, 75% of all stillbirths are caused by IUGR. IUGR is diagnosed by ultrasonography. In IUGR the uteroplacental blood flow is often compromised resulting in foetal growth restriction.

Design: The study is a prospective randomised study where pregnant women with suspected severe IUGR are randomised either to treatment with Innohep® or no treatment. Half of the women receive Innohep® and half of the women do not receive treatment.

Endpoints The primary endpoint is the difference in birth weight in children born of women receiving Innohep® during pregnancy and children born of women who have not received Innohep® during pregnancy

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Innohep

Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37

Drug: Innohep (Tinzaparin)
Dose: 4,500 IU daily in half of the study populationrandomised to treatment
Other Names:
  • Innohep

    • Drug: tinzaparin
    Dose 4,500 IE daily
    Other Names:
  • Innohep

    		•
    No Intervention: no treatment

    Outcome Measures

    Primary Outcome Measures

    1. birth weight [Birth weight registered at birth]

      We compare birth weight in children born of women from the 2 study arms

    Secondary Outcome Measures

    1. maternal morbidity [Comorbidity registered up to one year after birth]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Singleton pregnancy

    2. IUGR shown by ultrasonography:

    3. Can understand and read Danish

    Exclusion Criteria:

    1. Age below 18 years

    2. Pregestational weight < 90 kilograms

    3. Not able to give informed consent

    4. Chronic kidney disease with creatinine >150 μmol/l

    5. Chronic hypertension with blood pressure >140/90 mmHg

    6. Diabetes mellitus; type 1 or 2 or gestational diabetes

    7. Inflammatory bowel disease

    8. Severe heart disease (including mechanical heart valves)

    9. Drug or alcohol abuse

    10. Known coagulopathy (von Willebrand disease, thrombocytopenia, carrier of haemophilia)

    11. Treatment with vitamin K antagonists

    12. Known allergy to low LMWH

    13. Previous heparin-induced thrombocytopenia (HIT (type II))

    14. Clinically significant bleeding within the last month

    15. Women with indication for prophylactic treatment with LMWH during pregnancy e.g. previous thromboembolic disease or serious types of thrombophilia (deficiency of antithrombin, protein C or protein S)

    16. Chromosome anomaly in the child

    17. Severe malformations in the child

    18. Contraindication to Innohep®

    19. Gestational week > 32 weeks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Consultant phD professor Anne-Mette Hvas Aarhus Central Denmark Region Denmark 8200
    2 Department of Obstetrics Herning Denmark 7400
    3 Department of Obstetrics Randers Denmark

    Sponsors and Collaborators

    • University of Aarhus
    • Aarhus University Hospital
    • LEO Pharma

    Investigators

    • Principal Investigator: Anne-Mette Hvas, PhD, professor, Department of Clinical Biochemistry, Aarhus University Hospital, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01390051
    Other Study ID Numbers:
    • M-20110042
    First Posted:
    Jul 8, 2011
    Last Update Posted:
    Aug 18, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by University of Aarhus
    birth weight
    thrombosis
    anticoagulant therapy
    Additional relevant MeSH terms:
    Fetal Growth Retardation
    Birth Weight
    Tinzaparin
    Heparin, Low-Molecular-Weight
    Dalteparin

    Study Results

    No Results Posted as of Aug 18, 2016