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临床试验/NCT06031142
NCT06031142已完成不适用

Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.

Fudan University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年5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
4
试验地点
1
主要终点
The performance of this system in extracting fetal electrocardiogram (FECG)

研究概览

简要总结

The goal of this observational is to compare in describing fetal health conditions. The main questions it aims to answer are:

  • fetal electrocardiogram (fetal heart rate and fetal rhythm)
  • electrohysterography (uterine contractions).

Participants will wear wearable devices and CTG equipment for monitoring for 30 minutes.If there is a comparison group: Researchers will compare clinical CTG equipment to see if this wearable device.

详细描述

The investigators put the patch of the wearable device on the abdomen of the pregnant woman and continued the test for thirty minutes.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women with a gestational cycle greater than 36 weeks

排除标准

  • Pregnant women with a gestational cycle less than 36 weeks

结局指标

主要结局

The performance of this system in extracting fetal electrocardiogram (FECG)

时间窗: 2022.01-2023.08

extract fetal QRS intervals and numbers from FECG

The performance of this system in extracting electrohysterography (EHG)

时间窗: 2022.01-2023.08

use the contractions consistency index (CCI) parameters to analyze the relation between our measured EHG signal and the UC signal recorded by clinical CTG equipment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Li

Principal Investigator

Fudan University

研究点 (1)

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