anti10a Levels in Women Treated With LMWH in the Postpartum Period

Study Overview
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Brief Summary
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The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg

Detailed Description
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pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia. This risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (PE). The American College Of Obstetrics and Gynecologists, The American college of chest physicians and The Royal College of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a. This study will compare between two protocols based on anti-10a levels.

Official Title
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anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: clexane (LMWH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postpartum women supposed to receive LMWH according to obstetric indications Exclusion Criteria: known allergy to clexane active bleeding postpartum thrombocytopenia < 75000 recent cerebrovascular accident / transient ischemic attack (<4 weeks) glomerular filtration rate) < 30 ml/min) active liver disease malignant hypertension (systolic > 200 mmHg, diastolic> 120 mmHg)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clexane according to weight group<br>clexane dose adjusted for woman's weight according to: weight < 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, >170kg-100mg. | Drug: clexane (LMWH)<br>* to compare tow doses of clexane for preventing VTE in postpartum women<br>|
| Active Comparator: clexane mg per kg<br>clexane dose of 1mg/kg up to 120 mg | Drug: clexane (LMWH)<br>* to compare tow doses of clexane for preventing VTE in postpartum women<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clexane dosing method in order to achieve anti 10a level >0.2 |  | 4 hour after the women receive the drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of anti 10a level of >0.6 |  | 4 hour after the women receive the drug | 
| incidence of vein thromboembolism |  | during the six weeks after delivery | 
| incidence of bleeding events |  | during the six weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum venous thromboembolism, prophylactic dose of low molecular weight heparin, anti 10a