LMWH to Prevent Preeclampsia and Fetal Growth Restriction

This study has been terminated.
Sponsor:
Information provided by:
University of Florence
ClinicalTrials.gov Identifier:
NCT00260520
First received: November 30, 2005
Last updated: March 3, 2006
Last verified: December 2003

November 30, 2005
March 3, 2006
January 2002
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The composite primary outcome measure will be the occurrence of preeclampsia, fetal growth restriction FGR or both.
Complete list of historical versions of study NCT00260520 on ClinicalTrials.gov Archive Site
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Perinatal death, abruptio placentae, cesarean section, gestational age at delivery, placental weight, birth weight distribution by centile, the growth rate of fetal fat and lean body mass, and rate of maternal complications.
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LMWH to Prevent Preeclampsia and Fetal Growth Restriction
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

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.

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.

Observational
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Preeclampsia
Drug: Dalteparin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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December 2003
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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
Female
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00260520
06-03-1942
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University of Florence
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Study Director: Giorgio Mello, MD Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy
University of Florence
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP