Thromboembolism in the Puerperium Clinical Trial
Official title:
Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis
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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