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
  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 4

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00260520     History of Changes
Other Study ID Numbers: 06-03-1942
Study First Received: November 30, 2005
Last Updated: March 3, 2006
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

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

ClinicalTrials.gov processed this record on October 20, 2014