Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Biomarkers ratio
研究概览
简要总结
Prospective, observational, monocentric, non-interventional study.
详细描述
In practice, patients with preeclampsia are referred to the hospital for medical management only clinical signs & symptoms and standard biological tests are available for patient individualized care. Hence, a new diagnostic tool to distinguish and stratify the different patients referred is in need of proper triage.
REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women.
Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed preeclampsia
- •Singleton pregnancy
- •Between 26 weeks of gestation and 37 weeks of gestation & 6 days
排除标准
- •Multiple pregnancies
结局指标
主要结局
Biomarkers ratio
时间窗: Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia
sFlt-1/PlGF ratio
次要结局
- Biomarkers ratio(Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia)
- Fetal outcome(Date of delivery)
- Maternal outcome(From date of inclusion until the date of first documented event, assessed up to 24 weeks)