NCT03982654已完成不适用
Investigating the Physiology of Labour, Labour Onset and Pregnancy Outcomes in Pregnant Women, Through Longitudinal Measurements Performed With a Wearable Sensor
Bloom Technologies4 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2018年3月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 4
- 主要终点
- Accuracy
研究概览
简要总结
The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home.
Women participating in the study will be asked to regularly record data with the Bloomlife sensor, from inclusion in the study until delivery. In addition, clinical information related to their pregnancy and delivery will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 between 20 weeks and 0 days and 30 weeks and 0 days
- •Willingness to participate in the study
排除标准
- •Implanted pacemaker or any other implanted electrical device
- •History of allergies to silicone-based adhesives
- •Any health condition resulting in higher chance of C-section (meeting one of these criteria is sufficient to be excluded): previous history of C-section, placental abnormality, being primipara and older than 40
研究组 & 干预措施
Bloomlife
Experimental
干预措施: Bloomlife (Device)
结局指标
主要结局
Accuracy
时间窗: At delivery
Accuracy of the machine learning model for the automatic detection of labor, measured in terms of sensitivity and specificity in detecting labour
次要结局
- Labour probability(At delivery)
研究者
研究点 (4)
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