Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

Study Overview
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Brief Summary
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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
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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

Official Title
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Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial

Conditions
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Venous Thromboembolic Diseases

Intervention / Treatment
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* Drug: Bemiparin
* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 48 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bemiparin<br>A new second generation Low Molecular Weight Heparin | Drug: Bemiparin<br>* 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.<br>* Other names: Hibor; Laboratories Rovi Pharmaceuticals;Drug: Enoxaparin<br>* 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.<br>* Other names: Clexane(Sanofi aventis);|
| Active Comparator: Enoxaparin<br>A well known Low Molecular Weight Heparin | Drug: Enoxaparin<br>* 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.<br>* Other names: Clexane(Sanofi aventis);|
| No Intervention: control group<br>Risky group patients for VTE, but they will not receive any thromboprophylactic drug. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism | compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases. | 40 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects | bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence | after receiving the injections and till 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep vein thrombosis, Pulmonary embolism, Low molecular weight heparin, Enoxaparin, Bemiparin