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TerminatedNCT00260520Updated Mar 6, 2006

LMWH to Prevent Preeclampsia and Fetal Growth Restriction

An observational study in Preeclampsia, sponsored by University of Florence. Terminated. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-03-06.

Sponsored by University of Florence · Observational

Study type
Observational
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Preeclampsia

Keywords

  • Low molecular weight heparin
  • Preeclampsia
  • Fetal Growth Restriction
  • Thrombophilia
  • Factor V Leiden
  • G20210A prothrombin gene mutation
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

Browse Pre-Eclampsia studies →

Lead sponsor

University of Florence is the lead sponsor of 75 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Interventions

  • DrugDalteparin
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00260520
Lead sponsor
University of Florence
First posted
Dec 1, 2005
Start date
Jan 2002
Completion
Dec 2003
Last update
Mar 6, 2006

Study contacts

Giorgio Mello, MD
study director · Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.

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