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LMWH to Prevent Preeclampsia and Fetal Growth Restriction

Information source: University of Florence
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preeclampsia

Intervention: Dalteparin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Florence

Official(s) and/or principal investigator(s):
Giorgio Mello, MD, Study Director, Affiliation: Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy

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.

Clinical Details

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 design: N/A

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

Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Female.

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

Locations and Contacts

Additional Information

Starting date: January 2002
Last updated: March 3, 2006

Page last updated: August 20, 2015

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