Preeclampsia
Conditions
Keywords
Low molecular weight heparin, Preeclampsia, Fetal Growth Restriction, Thrombophilia, Factor V Leiden, G20210A prothrombin gene mutation
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.
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.
Interventions
DRUGDalteparin
Sponsors
University of Florence
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Outcome results
None listed