NCT00260520

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2002

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
Last Updated

March 6, 2006

Status Verified

December 1, 2003

First QC Date

November 30, 2005

Last Update Submit

March 3, 2006

Conditions

Preeclampsia

Keywords

Low molecular weight heparinPreeclampsiaFetal Growth RestrictionThrombophiliaFactor V LeidenG20210A prothrombin gene mutation

Interventions

DalteparinDRUG

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Previous severe preeclampsia
  • Previous severe fetal growth restriction
  • Heterozygous Factor V Leiden
  • Heterozygous G20210A prothrombin gene mutations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pre-EclampsiaFetal Growth RetardationThrombophilia

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Giorgio Mello, MD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 1, 2005

Study Start

January 1, 2002

Study Completion

December 1, 2003

Last Updated

March 6, 2006

Record last verified: 2003-12