Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)
详细描述
Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue 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
- Single (Outcomes Assessor)
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
Early Enoxaparin initiation
Women will start Enoxaparin therapy once positive pregnancy test is established
干预措施: Enoxaparin (Drug)
Later Enoxaparin initiation
Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: After 12 weeks gestational age
Number of pregnancies that progressed beyond the critical first trimester (12 weeks gestational age) per number of pregnant women
次要结局
- Fetal loss(From 20 weeks to 42 weeks gestational age)
- Preterm delivery(From 20 weeks to 34 weeks gestational age)
- Congenital fetal malformations(At birth)
- Intrauterine growth restriction (IUGR)(At birth)
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University