Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

Study Summary

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.

Primary Outcome

All events of symptomatic deep venous thrombosis in subjects will be recorded from the the date of randomization up to 6 weeks postpartum. Definition of symptomatic deep venous thrombosis (DVT): Suspected (recurrent) DVT with one of the following findings: If there were no previous DVT investigations: * Abnormal compression ultrasound (CUS), * An intraluminal filling defect on venography. If there was a previous DVT investigation: * Abnormal CUS where compression had been normal or, if non

Conditions Studied

Interventions

• DRUG Low dose nadroparin
• DRUG Intermediate dose nadroparin
• DRUG Low dose enoxaparin
• DRUG Intermediate dose enoxaparin
• DRUG Low dose dalteparin

Study Locations (20)