Trial | NCT01588171  Report issue

Title

Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum
Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    enoxaparin ...

  • Study Participants

    7020
The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for venous thrombosis.
Venous thromboembolism (VTE) is the leading cause of maternal mortality and morbidity in the developed and developing world. Pulmonary embolism and deep vein thrombosis are the two components of a single disease called deep vein thrombosis (DVT). Pregnancy associated with an average 5 to 10 fold increase in the risk of VTE compared with non-pregnant women. The highest incidence occurring during the post partum period. There are many researches done a broad on the effect of LMWH to decrease the incidence of VTE after Caesarean section using the two LMWH (Enoxaparin and Bemiparin) alone but not in one research comparing both of them alone and both together against a control group. Also according to our knowledge there are no published literature on thromboprophylaxis after vaginal delivery
Study Started
May 31
2012
Primary Completion
Oct 31
2013
Study Completion
Nov 30
2013
Last Update
Mar 18
2015
Estimate

Drug Bemiparin

Bemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after delivery(vaginal and Caesarean)and then daily for up to 7 days.

  • Other names: Hibor; Laboratories Rovi Pharmaceuticals

Drug Enoxaparin

Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients.

  • Other names: Clexane(Sanofi aventis)

Bemiparin Active Comparator

A new second generation Low Molecular Weight Heparin

Enoxaparin Active Comparator

A well known Low Molecular Weight Heparin

control group No Intervention

Risky group patients for VTE, but they will not receive any thromboprophylactic drug.

Criteria 

Inclusion Criteria:

Presence of risk factors for venous thromboembolism
Any parity
Mode of delivery:vaginal, Emergency and Elective Caesarean section
No any contraindications for Heparin

Exclusion Criteria:

Active antenatal or postpartum vaginal bleeding.
Placenta previa
Thrombocytopenia
Sever renal or liver diseases
Uncontrolled sever hypertension
Any patient who is already on Heparin during pregnancy
No Results Posted