A Cross-sectional, Interventional, Exploratory Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate
研究概览
简要总结
Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes.
In this study, Bloomlife Lovelace FT is used to collect the dataset needed for the development of a future product (Bloomlife Lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 greater or equal to 24 weeks and 0 days
- •Singleton pregnancy
- •Ability to read and understand Dutch
- •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 Bloomlife Lovelace FT electrodes locations
- •Contraindication to the use of CTG based on physician's decision (e.g. due to preterm contractions)
结局指标
主要结局
Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate
时间窗: 1 hour
Bland-Altman analysis, based on a 95% limits of agreement.
Extent of agreement between Bloomlife Lovelace FT and CTG in maternal heart rate
时间窗: 1 hour
Bland-Altman analysis, based on a 95% limits of agreement.
Performance metrics of Contraction Detection with Bloomlife Lovelace FT
时间窗: 1 hour
Sensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement.
次要结局
未报告次要终点