Beijing Anzhen Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Diagnostic efficiency of AI model for fetal CHD
研究概览
简要总结
This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Single or multiple pregnancy;
- •Gestational age 16-40 weeks;
- •Fetal echocardiographic images are clear and complete;
- •Clinical data are complete and detailed;
- •Sign informed consent and be able to cooperate with follow-up
排除标准
- •Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research;
- •Refusal or loss of follow-up
结局指标
主要结局
Diagnostic efficiency of AI model for fetal CHD
时间窗: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.
次要结局
未报告次要终点