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LMWH to Prevent Preeclampsia and Fetal Growth Restriction

This study has been terminated.
Study NCT00260520.   Last updated on March 3, 2006.   Information provided by University of Florence

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Descriptive Information Fields
Brief Title  LMWH to Prevent Preeclampsia and Fetal Growth Restriction
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
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.

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 Phase Phase IV
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Preeclampsia
Intervention  Drug: Dalteparin
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment 
Start Date  January 2002
Completion Date December 2003
Eligibility 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
Gender Female
Ages 20 Years to 40 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00260520
Organization ID 06-03-1942
Secondary IDs ††
Study Sponsor  University of Florence
Collaborators ††
Investigators 
Study Director:     Giorgio Mello, MD     Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy    
Information Provided By University of Florence
Verification Date December 2003
First Received Date  November 30, 2005
Last Updated Date March 3, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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