LMWH to Prevent Preeclampsia and Fetal Growth Restriction

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00260520
• Other study ID #: 06-03-1942
• Status: Terminated
• Phase: Phase 4
• First received: November 30, 2005
• Last updated: March 3, 2006
• Start date: January 2002
• Est. completion date: December 2003

Study information

• Verified date: December 2003
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Dalteparin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence