Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy
Condition: Deep Venous Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Low dose nadroparin; Intermediate dose nadroparin; Low dose enoxaparin; Intermediate dose enoxaparin; Low dose dalteparin; Intermediate dose dalteparin; Fixed low dose tinzaparin; Intermediate dose tinzaparin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Fixed low dose nadroparin:
< 100 kg: 2850 IU subcutaneously once-daily
100 kg and above: 3800 IU subcutaneously once-daily; Intermediate weight-adjusted dose nadroparin:
< 50 kg: 3800 IU subcutaneously once-daily;
50 to < 70 kg: 5700 IU subcutaneously once-daily;
70 to < 100 kg: 7600 IU subcutaneously once-daily;
100 kg or above: 9500 IU subcutaneously once-daily.; Fixed low dose enoxaparin:
< 100 kg: 40 mg subcutaneously once-daily
100 kg and above: 60 mg subcutaneously once-daily; Intermediate weight-adjusted dose enoxaparin:
< 50 kg: 60 mg subcutaneously once-daily, or;
50 kg to < 70 kg: 80 mg subcutaneously once-daily, or;
70 kg to < 100 kg: 100 mg subcutaneously once-daily, or;
100 kg or above: 120 mg subcutaneously once-daily.; Fixed low dose dalteparin:
< 100 kg: 5000 IU subcutaneously once-daily
100 kg and above: 7500 IU subcutaneously once-daily; Intermediate weight-adjusted dose dalteparin:
< 50 kg: 7500 IU subcutaneously once-daily, or;
50 kg to < 70 kg: 10000 IU subcutaneously once-daily, or;
70 kg to < 100 kg: 12500 IU subcutaneously once-daily, or;
100 kg or above: 15000 IU subcutaneously once-daily.; Fixed low dose tinzaparin:
< 100 kg: 3500 IU subcutaneously once-daily
100 kg and above: 4500 IU subcutaneously once-daily; Intermediate weight-adjusted dose tinzaparin:
< 50 kg: 4500 IU subcutaneously once-daily, or;
50 kg to < 70 kg: 7000 IU subcutaneously once-daily, or;
70 kg to < 100 kg: 10000 IU subcutaneously once-daily, or;
100 kg or above: 12000 IU subcutaneously once-daily.
Other intervention name(s): nadroparin; Fraxiparin; nadroparin; Fraxiparin; enoxaparin; Clexane; enoxaparin; Clexane; dalteparin; Fragmin; dalteparin; Fragmin; tinzaparin; Innohep; tinzaparin; Innohep
Intervention MeSH terms: Enoxaparin; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight; Nadroparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Low-molecular-weight heparin; Pregnancy; Venous thrombosis