Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Anticardiolipin antibodies
研究概览
简要总结
The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 24-34 weeks
- •Diagnosis of severe preeclampsia
排除标准
- •Known antiphospholipid syndrome.
- •Known presence of antiphospholipid antibodies.
- •Patients with systemic lupus erythematosus.
结局指标
主要结局
Anticardiolipin antibodies
时间窗: 15 months
Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies.
Lupus anticoagulant
时间窗: 15 months
Number of cases positive for Lupus Anticoagulant.
B2 Glycoprotein I
时间窗: 15 months
Number of cases with levels of B2 Glycoprotein 1 \> 99%
次要结局
未报告次要终点
研究者
Osvaldo A. Reyes T.
MD
Saint Thomas Hospital, Panama
