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

This study is currently recruiting participants.
Verified March 2012 by University of Aarhus
Sponsor:
Collaborators:
Aarhus University Hospital
LEO Pharma
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01390051
First received: July 6, 2011
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • birth weight [ Time Frame: until november 2013 ] [ 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: until November 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 204
Study Start Date: July 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (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 population that are randomised 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390051

Contacts
Contact: Anne-Mette Hvas, MD +45 8949 5100 annehvas@rm.dk
Contact: Anette T Hansen, MD +45 8949 5392 anette.tarp.hansen@rm.dk

Locations
Denmark
Consultant Anne-Mette Hvas Recruiting
Aarhus, Central Denmark Region, Denmark, 8200
Contact: Anette Tarp Hansen, MD     +45 8949 5392     anette.tarp.hansen@rm.dk    
Sub-Investigator: Anette T Hansen, MD            
Principal Investigator: Anne-Mette Hvas, MD            
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
LEO Pharma
Investigators
Principal Investigator: Anne-Mette Hvas, MD Department of Clinical Biochemistry, Aarhus University Hospital, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01390051     History of Changes
Other Study ID Numbers: M-20110042
Study First Received: July 6, 2011
Last Updated: March 20, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
birth weight
thrombosis
anticoagulant therapy

Additional relevant MeSH terms:
Fetal Diseases
Birth Weight
Fetal Growth Retardation
Body Weight
Signs and Symptoms
Pregnancy Complications
Growth Disorders
Pathologic Processes
Heparin, Low-Molecular-Weight
Dalteparin
 Tinzaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013