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

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

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

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:

Genetics Home Reference related topics: factor V Leiden thrombophilia prothrombin thrombophilia

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	06-03-1942
Study First Received:	November 30, 2005
Last Updated:	March 3, 2006
ClinicalTrials.gov Identifier:	NCT00260520 History of Changes
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
Anticoagulants
Pregnancy Complications
Eclampsia
Factor V Leiden Thrombophilia
Heparin, Low-Molecular-Weight
Thrombophilia
Pre-Eclampsia
Fibrinolytic Agents
Cardiovascular Agents
Preeclampsia

Calcium heparin
Body Weight
Fibrin Modulating Agents
Fetal Diseases
Hypertension, Pregnancy-Induced
Dalteparin
Growth Disorders
Heparin
Fetal Growth Retardation
Hypertension

Additional relevant MeSH terms:

Pregnancy Complications
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Heparin, Low-Molecular-Weight
Hematologic Agents
Pre-Eclampsia
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

Fibrin Modulating Agents
Fetal Diseases
Hypertension, Pregnancy-Induced
Pathologic Processes
Dalteparin
Therapeutic Uses
Growth Disorders
Fetal Growth Retardation

ClinicalTrials.gov processed this record on July 06, 2009