Safety of Fondaparinux as Post Partum Thromboprophylaxis

Study Overview
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Brief Summary
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Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. The investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis. The investigators planned a prospective, single arm, open label study. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for 10 days. The investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.

Detailed Description
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All women were taught the injection technique and counselled regarding the symptoms of bleeding and VTE, prior to discharge. All patients were also advised to wear compression stockings and ensure adequate hydration at home The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also recorded.

Official Title
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Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis

Conditions
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Thromboembolism in the Puerperium

Intervention / Treatment
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* Drug: Fondaparinux 2.5Mg/0.5Ml Inj Syr


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malaysian Age 18 and above Scores asintermediate risk on 2015 Royal College of Obstetricians & Gynaecologists (RCOG) VTE risk assessment Exclusion Criteria: Hypersensitivity to fondaparinux Patients with bleeding disorders - haemophilia , thrombocytopenia, von Willebrand's disease. Weight < 50 kg Patients with primary postpartum haemorrhage Patients who already on anti - coagulants Medical co morbidities - Systemic lupus erythematosus, heart failure, nephrotic syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user Uncontrolled hypertension ( blood pressure > 200 mmHg systolic or > 120 mmHg diastolic )

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fondaparinux<br>Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis | Drug: Fondaparinux 2.5Mg/0.5Ml Inj Syr<br>* post natal thromboprophylaxis<br>* Other names: N/A; single arm study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism (VTE) | VTE occurence of either deep vein thrombosis or pulmonary embolism | Within six weeks of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Bleeding requiring hospitalisation | Secondary post partum haemorrhage or spinal site bleeding | within six weeks of delivery | 
| Minor bleeding | Wound site bleeding, skin bruising | within six weeks of delivery | 
| Allergic reaction | Any allergy symptoms following injection of fondaparinux | within 24 hours from last injection | 
| Neonatal bleeding tendency | Any bruising of bleeding tendency in neonates | within six weeks of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, thromboembolism, prophylaxis