LMWH to Prevent Preeclampsia and Fetal Growth Restriction
Primary Purpose
Preeclampsia
Status
Terminated
Phase
Locations
Study Type
Observational
Intervention
Dalteparin
Sponsored by
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
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
NCT ID
NCT00260520
First Posted
November 30, 2005
Last Updated
March 3, 2006
Sponsor
University of Florence
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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