The Application Value of STIC in the Diagnosis of Fetal Complex Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Fetal Congenital heart disease
研究概览
简要总结
The objective of this study is to use of STIC technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.
详细描述
This is a diagnostic test in Shanghai Xinhua hospital from Nov.2016 to Dec.2017. 265 Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography.Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. Study participants will be asked for their informed consent.We collect their fetal 2D echocardiography and STIC images every 4-6 weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal echocardiography.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gravida with singleton pregnancy taking fetal echocardiography.
- •No virus infection or drug use history, no harmful substances in the early pregnancy.
- •Complete pregnancy check in the hospital, and finally delivery or abortion in the hospital.
- •On the basis of informed consent，willing to cooperate with our group.
排除标准
- •Elderly pregnant women (>35 years old)
- •Twin or multiple pregnancy
- •Pregnant women suffering from mental illness, can't take care of themselves.
- •Fetus diagnosed with other abnormalities (except congenital heart defects)
结局指标
主要结局
Fetal Congenital heart disease
时间窗: Nov 2016 to Dec 2018
If an enrolled gravida chooses to terminate her pregnancy, autopsy confirmation will be performed ;If the gravida continues her pregnancy, the outcome will be measured by neonatal echocardiography or surgery.
次要结局
未报告次要终点