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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of Aarhus
Aarhus University Hospital
LEO Pharma
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: July 6, 2011
Last updated: June 9, 2015
Last verified: March 2012
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 Intervention Phase
Fetal Growth Retardation
Drug: Innohep (Tinzaparin)
Drug: tinzaparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • birth weight [ Time Frame: Birth weight registered at birth ] [ Designated as safety issue: No ]
    We compare birth weight in children born of women from the 2 study arms

Secondary Outcome Measures:
  • maternal morbidity [ Time Frame: Comorbidity registered up to one year after birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 204
Study Start Date: July 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Innohep 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

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


Ages Eligible for Study:   18 Years and older
Genders 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 > 30 weeks
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01390051

Contact: Anne-Mette Hvas, PhD, professor +45 78455200
Contact: Anette Tarp Hansen, PhD +45 78463072

Consultant phD professor Anne-Mette Hvas Recruiting
Aarhus, Central Denmark Region, Denmark, 8200
Contact: Anette Tarp Hansen, MD, PhD    +45 78463072   
Sub-Investigator: Anette Tarp Hansen, MD, PhD         
Principal Investigator: Anne-Mette Hvas, Consultant, professor, PhD         
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
  More Information

Responsible Party: University of Aarhus Identifier: NCT01390051     History of Changes
Other Study ID Numbers: M-20110042 
Study First Received: July 6, 2011
Last Updated: June 9, 2015
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
birth weight
anticoagulant therapy

Additional relevant MeSH terms:
Fetal Diseases
Birth Weight
Fetal Growth Retardation
Body Weight
Growth Disorders
Pathologic Processes
Pregnancy Complications
Signs and Symptoms
Heparin, Low-Molecular-Weight
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on May 04, 2016