A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.
研究概览
简要总结
To compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.
详细描述
Previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. We undertook a RCT of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •history of two or more unexplained consecutive pregnancy losses prior to 32 weeks
- •presence of one of the panel of autoantibodies/thrombophilia markers
- •confirmed pregnancy
排除标准
- •known peptic ulcer disease
- •sensitivity to ASA or heparin
- •previous thrombotic event
- •geographic distance from clinic
- •failure to consent
研究组 & 干预措施
a
干预措施: Low molecular weight heparin and low dose aspirin (Drug)
b
Low dose aspirin only
干预措施: Low dose aspirin (Drug)
结局指标
主要结局
To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone.
时间窗: Duration of pregnancy
次要结局
- Secondary outcomes included adverse events and incidence of bone loss in the two groups.(pre-pregnancy through postpartum period)