Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,020
- 试验地点
- 1
- 主要终点
- Venous thromboembolism
研究概览
简要总结
The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for venous thrombosis.
详细描述
Venous thromboembolism (VTE) is the leading cause of maternal mortality and morbidity in the developed and developing world. Pulmonary embolism and deep vein thrombosis are the two components of a single disease called deep vein thrombosis (DVT). Pregnancy associated with an average 5 to 10 fold increase in the risk of VTE compared with non-pregnant women. The highest incidence occurring during the post partum period. There are many researches done a broad on the effect of LMWH to decrease the incidence of VTE after Caesarean section using the two LMWH (Enoxaparin and Bemiparin) alone but not in one research comparing both of them alone and both together against a control group. Also according to our knowledge there are no published literature on thromboprophylaxis after vaginal delivery
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
A prospective non-randomized clinical trial, no masking was applied to the 3 arms of the study
入排标准
- 年龄范围
- 15 Years 至 48 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of risk factors for venous thromboembolism
- •Any parity
- •Mode of delivery:vaginal, Emergency and Elective Caesarean section
- •No any contraindications for Heparin
排除标准
- •Active antenatal or postpartum vaginal bleeding.
- •Placenta previa
- •Thrombocytopenia
- •Sever renal or liver diseases
- •Uncontrolled sever hypertension
- •Any patient who is already on Heparin during pregnancy
研究组 & 干预措施
Bemiparin
A new second generation Low Molecular Weight Heparin
干预措施: Bemiparin (Drug)
Bemiparin
A new second generation Low Molecular Weight Heparin
干预措施: Enoxaparin (Drug)
Enoxaparin
A well known Low Molecular Weight Heparin
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Venous thromboembolism
时间窗: 40 days after delivery
compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases.
次要结局
- adverse effects(after receiving the injections and till 40 days)
研究者
SHAHLA KAREEM ALALAF
Assistant Professor
Hawler Medical University