Prospective data collection of obstetric ultrasound scans for development of AI solutions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Data collected from about 500 pregnant women aged 18 years or more, with different presentations, gestational ages, placental positions, single or multiple pregnancies, growth abnormalities, abnormal umbilical artery doppler etc.
研究概览
简要总结
This is a prospective data collection study.
The main objective of the study is to collect ultrasound imaging data with the Lumify C5-2 ultrasound system in at least 500 pregnant women using blind and guided sweep protocols to design and develop algorithms for automated / semi-automated detection of the basic obstetric ultrasound screening parameters.
To build clinically useful algorithms, the data collected is planned to represent a variety of conditions and variations seen in normal clinical practice: hence the dataset should contain at least some of the following variables such as
· Different fetal positions and presentations
· Different gestational ages
· Different placenta locations,
· Pregnancies with various amounts of amniotic fluid.
· Singleton as well as multiple pregnancies.
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研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female subjects, aged 18 years or more, presenting for a routine or referred ultrasound scan with:
- •A pregnancy of 7 weeks or more than 7 weeks of gestation.
- •Singleton pregnancy or multiple pregnancy
- •Normal pregnancy or abnormal pregnancy (maternal or fetal conditions)
- •Willing and able to provide informed consent.
排除标准
- •Pregnant women aged below 18 years.
- •Pregnancy less than 7 weeks gestation.
- •Subjects presenting with any condition that needs emergency care (as per investigator’s discretion).
- •Subject unwilling or unable to provide informed consent, such as those with neurological or psychiatric or other conditions that affect the subject’s understanding of the information provided with the consent form.
结局指标
主要结局
Data collected from about 500 pregnant women aged 18 years or more, with different presentations, gestational ages, placental positions, single or multiple pregnancies, growth abnormalities, abnormal umbilical artery doppler etc.
时间窗: Data collected for a period of about 12 months
次要结局
未报告次要终点