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临床试验/NCT04450251
NCT04450251已完成不适用

Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal

Owlet Baby Care, Inc.1 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2018年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
1
主要终点
The objective of this study is to collect observational fetal ECG readings with a novel wearable device

研究概览

简要总结

Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight "at-home" fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Pregnant woman, 18 years of age and up.
  • Singleton or twin pregnancy.

排除标准

  • Self-reported substance abuse problems.
  • Anyone unable or unwilling to give informed consent.

结局指标

主要结局

The objective of this study is to collect observational fetal ECG readings with a novel wearable device

时间窗: Up to 16 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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