A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care 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
- 96
- 试验地点
- 2
- 主要终点
- Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate
研究概览
简要总结
Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.
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
- •Pregnant woman ≥ 18 years old
- •Gestational age ≥ 32 weeks and 0 days
- •Singleton pregnancy
- •Ability to read and understand Dutch or English
- •Willingness to participate in the study
排除标准
- •Implanted pacemaker or any other implanted electrical device
- •Plurality higher than 1
- •History of allergies to skin adhesives
- •Contraindication to the use of the CTG
结局指标
主要结局
Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate
时间窗: 1 hour
Bland-Altman analysis, based on a 95% limits of agreement
Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate
时间窗: 1 hour
Bland-Altman analysis, based on a 95% limits of agreement
次要结局
未报告次要终点