Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Deep Vein Thrombosis (DVT), Pulmonary Embolism

Intervention / Treatment
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* Drug: Bemiparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female undergoing Benign gynecological surgeries. Having moderate,high and very high risk factors for venous thromboembolism. No contraindications for the use of Heparin. Exclusion Criteria: Having mild risk factors for thromboembolism. Active vaginal bleeding. Thrombocytopaenia. any patient who is already on anticoagulant. Sever renal or Liver diseases.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bemiparin<br>group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin | Drug: Bemiparin<br>* 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.<br>* Other names: Hibor; Laboratories Rovi pharmaceuticals;|
| No Intervention: control group<br>women will undergo benign gynaecological surgeries and are risky for venous thrombosis, they will not receive any intervention. The patients will be followed up to 30 days after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidences of clinical thromboembolic disease after gynaecological surgeries | to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries | within the first 30 days after surgery the first 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the side effects of Bemiparin injection | To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding, | after receiving the injections and up to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboprophylaxis, Bemiparin, Low Molecular Weight Heparin, Major Gynaecological Surgeries, Benign Gynaecological Surgeries