LMWH to Prevent Preeclampsia and Fetal Growth Restriction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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Preeclampsia

Interventions

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Dalteparin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Giorgio Mello, MD

Role: STUDY_DIRECTOR

Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy

Other Identifiers

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06-03-1942

Identifier Type: -

Identifier Source: org_study_id