Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Duration of ultrasound examination
研究概览
简要总结
This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, during the second trimester ultrasound scan.
详细描述
In recent years in many ultrasound equipment were fitted with automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy. Although there are studies that have assessed the application of these algorithms in terms of repeatability of the measurements made, or of possibility of acquiring diagnostic planes, there are no randomized controlled studies that evaluated their impact on the second trimester ultrasound scan.
The aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, in terms of:
- duration of the ultrasound scan
- quality of biometric measurements
- quality of the diagnostic planes
- operator satisfaction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy 19+0-21+6 weeks
- •Live fetus
- •No fetal abnormalities
排除标准
- •Multiple pregnancy
- •Intrauterine fetal death
- •Fetal abnormalities
结局指标
主要结局
Duration of ultrasound examination
时间窗: During ultrasound examination
Duration of ultrasound examination in minutes
次要结局
- Quality score of fetal diagnostic planes(During ultrasound examination)
- Operator satisfaction(During ultrasound examination)
- Quality score of fetal biometry(During ultrasound examination)
研究者
Federico Prefumo
Associate Professor
Università degli Studi di Brescia