NCT01588171

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7,020 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: Female
• Age: 15 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Venous Thromboembolic Diseases

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2012-04-30
• Last updated: 2025-11-21

Locations

1 site across 1 country: Iraq