NCT05498298已完成不适用
A Cross-sectional, Interventional, Exploratory Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
Bloom Technologies2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年8月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Reliability in fetal heart rate extraction
研究概览
简要总结
Bloom Technologies is developing a wearable device for monitoring pregnancy.
In this study, Bloom Technologies wants to investigate the reliability of this new technology.
For this reason, a device that records very high-quality data (g,Hlamp) was chosen. The study device is attached to the body by means of electrodes (up to 32) that can be safely attached to the skin. Most of the electrodes are placed on the abdomen, and a few on the chest and back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Pregnant woman ≥ 18 years old
- •Gestational age ≥ 30 weeks and 0 days
- •Singleton pregnancy
- •Ability to read and understand English or Spanish
- •Willingness to participate in the study
排除标准
- •Implanted pacemaker or any other implanted electrical device
- •History of allergies to skin adhesives
- •Irritated or lesioned skin at the electrodes locations
结局指标
主要结局
Reliability in fetal heart rate extraction
时间窗: 40 minutes
Percentage of a recording with a fetal heart rate signal extracted
Reliability in maternal heart rate extraction
时间窗: 40 minutes
Percentage of a recording with a maternal heart rate signal extracted
次要结局
未报告次要终点
研究者
研究点 (2)
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