NCT01630148

Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 774 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: Female
• Age: 15 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women who undergo gynecologic surgery for benign conditions world wide and especially in developing countries including our region. Having a research in our locality for the first time might raise awareness of the importance of VTE prophylaxis.

Detailed description

Deep vein thrombosis (DVT) and pulmonary embolism (PE), also referred to as venous thromboembolic events (VTE), are two major complications after gynaecological surgeries that can result in significant morbidity and mortality. The incidence of VTE after gynaecologic surgery varies depending on the method used for diagnosis. The rate of clinical DVT is estimated to be 3% after gynaecological surgery if no thromboprophylaxis was used. The rate of VTE assumed to decrease to 0.4% if Low molecular weight heparin was used as a thromboprophylaxis. According to our knowledge there are no published researches on the effect of the new second generation Low molecular Weight Heparin Bemiparin as a thromboprophylaxis after benign gynaecological surgery in comparison to a control group.

Conditions

• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Bemiparin	Bemiparin Sodium 3,500IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group (Moderate, High and Highest risk groups for thromboembolism) 6 hours after surgery and then daily for up to 7 days.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-06-28
• Last updated: 2024-09-19

Locations

1 site across 1 country: Iraq