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LMWH to Prevent Preeclampsia and Fetal Growth Restriction

Primary Purpose

Preeclampsia

Status
Terminated
Phase
Locations
Study Type
Observational
Intervention
Dalteparin
Sponsored by
University of Florence
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Preeclampsia focused on measuring Low molecular weight heparin, Preeclampsia, Fetal Growth Restriction, Thrombophilia, Factor V Leiden, G20210A prothrombin gene mutation

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2005
    Last Updated
    March 3, 2006
    Sponsor
    University of Florence
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00260520
    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
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    December 2003
    Overall Recruitment Status
    Terminated
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Florence

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preeclampsia
    Keywords
    Low molecular weight heparin, Preeclampsia, Fetal Growth Restriction, Thrombophilia, Factor V Leiden, G20210A prothrombin gene mutation

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Dalteparin

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giorgio Mello, MD
    Organizational Affiliation
    Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    LMWH to Prevent Preeclampsia and Fetal Growth Restriction

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