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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fondaparinux | Experimental | Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fondaparinux 2.5Mg/0.5Ml Inj Syr | Drug | post natal thromboprophylaxis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism (VTE) | VTE occurence of either deep vein thrombosis or pulmonary embolism | Within six weeks of delivery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nor Azlin Mohamed Ismail, MBCHB, MMED | Faculty of Medicine, National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics & Gynaecology, Universiti Kebangsaan Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
IPD is available upon request
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 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 |