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LMWH to Prevent Preeclampsia and Fetal Growth Restriction

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ClinicalTrials.gov Identifier: NCT00260520
Recruitment Status : Terminated
First Posted : December 1, 2005
Last Update Posted : March 6, 2006
Sponsor:
Information provided by:
University of Florence

Brief Summary:
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 or disease Intervention/treatment
Preeclampsia Drug: Dalteparin

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.

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

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MedlinePlus related topics: Blood Thinners
U.S. FDA Resources





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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): NCT00260520


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

ClinicalTrials.gov Identifier: NCT00260520     History of Changes
Other Study ID Numbers: 06-03-1942
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: March 6, 2006
Last Verified: December 2003

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

Additional relevant MeSH terms:
Pre-Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action