Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Accuracy and reliability in the detection of foetal movements
研究概览
简要总结
The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.
Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.
The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.
Clinical information related to subjects' pregnancy and foetal health is also collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age of at least 20 weeks
- •Singleton pregnancy
- •Willingness to participate in the study
排除标准
- •Multiple pregnancy
- •Implanted pacemaker or any other implanted electrical device
- •History of allergies to silicone-based adhesives
结局指标
主要结局
Accuracy and reliability in the detection of foetal movements
时间窗: Throughout the subject's participation in the study, from inclusion until delivery
Foetal movements are detected from the collected sensor data and compared to the reference
Accuracy and reliability in the detection of foetal heart rate
时间窗: Throughout the subject's participation in the study, from inclusion until delivery
Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference
次要结局
未报告次要终点