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LMWH to Prevent Preeclampsia and Fetal Growth Restriction

This study has been terminated.

Sponsored by: University of Florence
Information provided by: University of Florence
ClinicalTrials.gov Identifier: NCT00260520
  Purpose

The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.


Condition Intervention Phase
Preeclampsia
Drug: Dalteparin
Phase IV

Genetics Home Reference related topics:   factor V Leiden thrombophilia   

ChemIDplus related topics:   Heparin   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation

Further study details as provided by University of Florence:

Study Start Date:   January 2002
Estimated Study Completion Date:   December 2003

Detailed Description:

The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.

  Eligibility
Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Previous severe preeclampsia
  • Previous severe fetal growth restriction
  • Heterozygous Factor V Leiden
  • Heterozygous G20210A prothrombin gene mutations

Exclusion Criteria:

  • renal disease
  • chronic hypertension
  • preexisting diabetes mellitus
  • homozygosity for Factor V Leiden
  • homozygosity for prothrombin G20210A mutation
  • hyperhomocysteinemia
  • protein C deficency
  • protein S deficency
  • antithrombin deficiency
  • positive anticardiolipin antibodies
  • positive lupus anticoagulant
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260520

Sponsors and Collaborators
University of Florence

Investigators
Study Director:     Giorgio Mello, MD     Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy    
  More Information

Study ID Numbers:   06-03-1942
First Received:   November 30, 2005
Last Updated:   March 3, 2006
ClinicalTrials.gov Identifier:   NCT00260520
Health Authority:   Italy: Ethics Committee

Keywords provided by University of Florence:
Low molecular weight heparin  
Preeclampsia  
Fetal Growth Restriction  
Thrombophilia
Factor V Leiden
G20210A prothrombin gene mutation

Study placed in the following topic categories:
Thrombin
Pregnancy Complications
Eclampsia
Heparin, Low-Molecular-Weight
Thrombophilia
Pre-Eclampsia
Preeclampsia
Calcium heparin
Body Weight
Fetal Diseases
Hypertension, Pregnancy-Induced
Dalteparin
Growth Disorders
Factor V Leiden thrombophilia
Pregnancy toxemia /hypertension
Heparin
Fetal Growth Retardation
Hypertension

Additional relevant MeSH terms:
Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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