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临床试验/NCT06683183
NCT06683183已完成不适用

Ability of the Polar Wearables to Detect Fetal Heart Rate - Pilot Clinical Study

Anna Axelin1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Fetal heart rate

研究概览

简要总结

The aim of this clinical pilot study is

  1. to evaluate the ability of the wearables to detect fetal heart rate
  2. to evaluate the ability to distinguish the fetal ECG from the ECG of the mother

The participating pregnant women will wear the Polar wearables (chest band, smart watch, arm band) for 15 minutes during of which, the data will be collected with all three wearables and patient monitor (reference device). The data from the wearables will be compared with the patient monitor data referred as golden standard. Background information will be collected with questionnaires from the participants. The data collection will be conducted in hospital environment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • duration of pregnancy at least 29+0 weeks
  • single pregnancy
  • age at least 18 years
  • ability to participate in Finnish. No exclusion criteria

排除标准

  • 未提供

结局指标

主要结局

Fetal heart rate

时间窗: 15 minute data collection

次要结局

未报告次要终点

研究者

发起方
Anna Axelin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anna Axelin

Professor

University of Turku

研究点 (1)

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