LMWH to Prevent Preeclampsia and Fetal Growth Restriction - Tabular View

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LMWH to Prevent Preeclampsia and Fetal Growth Restriction

This study has been terminated.

Study NCT00260520. Last updated on March 3, 2006. Information provided by University of Florence

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

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

Brief Summary

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.

Study Phase

Phase IV

Study Type ^†

Observational

Study Design ^†

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Preeclampsia

Intervention ^†

Drug: Dalteparin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

January 2002

Completion Date

December 2003

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

Gender

Female

Ages

20 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00260520

Organization ID

06-03-1942

Secondary IDs ^††

Study Sponsor ^†

University of Florence

Collaborators ^††

Investigators ^†

Study Director:

Giorgio Mello, MD

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

Information Provided By

University of Florence

Verification Date

December 2003

First Received Date ^†

November 30, 2005

Last Updated Date

March 3, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.