Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fetal loss
研究概览
简要总结
Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)
详细描述
Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
- •Early pregnancy body weight is 50-90 Kg
排除标准
- •Women with systemic lupus erythematosus (SLE)
- •Women with active thromboembolic disorders
- •Women with history of previous thromboembolic disorders
研究组 & 干预措施
Enoxaparin group
Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy
干预措施: Enoxaparin (Drug)
Warfarin group
Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester
干预措施: Warfarin (Drug)
结局指标
主要结局
Fetal loss
时间窗: From 12 weeks to 42 weeks gestational age
Unexplained fetal death of morphologically normal fetus after the first trimester
次要结局
- Preterm delivery(From 20 weeks to 34 weeks gestational age)
- Intrauterine growth restriction (IUGR)(At birth)
- Congenital fetal malformations(At birth)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University