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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01390051
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : August 18, 2016
Aarhus University Hospital
LEO Pharma
Information provided by (Responsible Party):
University of Aarhus

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
Fetal Growth Retardation Drug: Innohep (Tinzaparin) Drug: tinzaparin 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 Type : Interventional  (Clinical Trial)
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 : July 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

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 Name: Innohep

Drug: tinzaparin
Dose 4,500 IE daily
Other Name: Innohep

No Intervention: no treatment

Primary Outcome Measures :
  1. birth weight [ Time Frame: 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 [ Time Frame: Comorbidity registered up to one year after birth ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01390051

Consultant phD professor Anne-Mette Hvas
Aarhus, Central Denmark Region, Denmark, 8200
Department of Obstetrics
Herning, Denmark, 7400
Department of Obstetrics
Randers, Denmark
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
LEO Pharma
Principal Investigator: Anne-Mette Hvas, PhD, professor Department of Clinical Biochemistry, Aarhus University Hospital, Denmark

Responsible Party: University of Aarhus Identifier: NCT01390051     History of Changes
Other Study ID Numbers: M-20110042
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: July 2016

Keywords provided by University of Aarhus:
birth weight
anticoagulant therapy

Additional relevant MeSH terms:
Birth Weight
Fetal Growth Retardation
Body Weight
Signs and Symptoms
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action