Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Venous thromboembolism (VTE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Malaysian
- •Age 18 and above
- •Scores asintermediate risk on 2015 Royal College of Obstetricians & Gynaecologists (RCOG) VTE risk assessment
排除标准
- •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 )
研究组 & 干预措施
Fondaparinux
Subcutaneous injection of fondaparinux 2.5 mg once daily would be given over 10 days for post partum thromboprophylaxis
干预措施: Fondaparinux 2.5Mg/0.5Ml Inj Syr (Drug)
结局指标
主要结局
Venous thromboembolism (VTE)
时间窗: Within six weeks of delivery
VTE occurence of either deep vein thrombosis or pulmonary embolism
次要结局
- Major Bleeding requiring hospitalisation(within six weeks of delivery)
- Minor bleeding(within six weeks of delivery)
- Allergic reaction(within 24 hours from last injection)
- Neonatal bleeding tendency(within six weeks of delivery)
研究者
Aida Hani Mohd Kalok
Lecturer & Clinical Specialist
National University of Malaysia