Essai thérapeutique randomisé Multicentrique en Double Insu, Comparant l'énoxaparine 40mg Versus Placebo, en Une Injection Sous-cutanée Quotidienne, Dans Les Fausses Couches spontanées récurrentes inexpliquées
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 258
- 试验地点
- 7
- 主要终点
- Alive and Viable Births
研究概览
简要总结
Standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent spontaneous abortion. Prothrombotic mechanisms were initially evoked. Factor V Leiden, Prothrombin G20210A mutation and protein S deficiency are implicated in the meta-analysis of Rey (Lancet).However, they do not account for a large number of miscarriages.Gris JC and coworkers (Blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. They conclude for a benefit action of Low-molecular-weight heparin. There is actually no trials concerning women with unexplained recurrent abortions and without known thrombophilia. Nevertheless,aspirin or enoxaparin are often prescribed. It is time to assess these practices. We therefore initiate a multisite, double blind randomized study, enoxaparine versus placebo, in women without known thrombophilia, which experienced unexplained recurrent abortions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 45 years
- •2 or more consecutive spontaneous abortions before the 15th week of pregnancy
- •Unexplained abortions
- •No maternal or paternal characterized chromosomal aberration
- •No Anti-phospholipid Syndrome
- •No anatomical abnormality possibly responsible for abortion
- •No Factor V Leiden
- •No Prothrombin G20210A mutation
- •No protein S deficiency
- •No protein C deficiency
- •No Anti thrombin 3 deficiency
- •Proved pregnancy
排除标准
- •Contraindications of enoxaparine 4000 U per day
- •Women with risk of venous thromboembolism during pregnancy
- •No regular anticoagulation or antiplatelet treatment
- •Blood Hemoglobin level below 10g/dl
- •Blood platelet level below 150 000/mm3
- •Creatinine clearance below 30ml/mn
- •Anomaly of the coagulation tests
- •No informed consent
研究组 & 干预措施
2
干预措施: placebo (Drug)
1
干预措施: enoxaparine 40 mg daily (Drug)
结局指标
主要结局
Alive and Viable Births
时间窗: number of born child healthy
次要结局
未报告次要终点
