A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
研究概览
简要总结
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
详细描述
The study consisted of 2 phases: a pilot phase and a pivotal phase. The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study. The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
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 English or Spanish
- •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
- •Irritated or lesioned skin at the Bloomlife MFM-Pro electrodes locations
- •Contraindication to the use of CTG
结局指标
主要结局
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
时间窗: 5 minutes
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
时间窗: 5 minutes
次要结局
未报告次要终点