NCT04343482已完成不适用
Wireless Wearable Maternal Fetal Sensors for Non-Stress Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Device comparison to standard monitoring
研究概览
简要总结
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age >18 years old
- •Pregnant mothers >26 weeks undergoing nonstress testing or delivering
- •Singleton pregnancy
- •No fetal abnormality or chromosomal abnormality
- •Subjects willing and able to comply with requirements of the protocol
- •Nurses and clinicians who will be administering the non-stress test to the pregnant subject
排除标准
- •Women who refuse to signed the informed consent form
- •Maternal age under 18 years old
- •Multiple pregnancy
- •Known major fetal malformation or chromosomal abnormality
- •Medical or obstetric problem that would preclude the use of abdominal electrodes
- •Inability to consent to this study due to medical illness, diminished intellectual capacity, or language barrier
- •Women using pacemakers
结局指标
主要结局
Device comparison to standard monitoring
时间窗: 3 years
The primary outcome measure is concordance of FHR tracing assessments from Rogers sensor recordings with those obtained from the current standard of care electronic fetal monitoring systems.
次要结局
- Qualitative analyses of sensor output(3 years)
研究者
Shuai (Steve) Xu
Principal Investigator
Northwestern University
研究点 (1)
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