drugset / Trial / NCT00878826

Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.

NCT00878826

Phase 2/3 Completed 11 enrolled Stanford University
RandomizedParallel-groupOpen-labelPrevention

Summary

Enoxaparin is a type of low molecular weight heparin (LMWH), or anticoagulant, used to prevent and treat blood clots. Formation of blood clots, or venous thromboemboli (VTE) in pregnancy can have dangerous and even life-threatening effects on the mother and fetus. Enoxaparin is the preferred medicine to prevent clotting in pregnant patients who are at risk for VTE, because it has been studied to be safe and effective in pregnancy without any harms to the fetus. Although this medication is routinely used and is recommended by several prominent medical groups, the optimal dosing for prevention of VTE is still unclear. The range of standardly prescribed dosing regimens of Enoxaparin includes 40mg daily and 1mg/kg daily, but these two dosing strategies have never been compared in a head to head fashion.

Timeline

Start
2009-05
Primary completion
2011-08
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 1 mg/kg Subcutaneous
Comparator Enoxaparin sodium Other / unclassified 40 mg Subcutaneous