LMWH to Prevent Preeclampsia and Fetal Growth Restriction - Full Text View

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

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