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Clinical Trials/NCT06031142
NCT06031142
Completed
N/A

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

Fudan University1 site in 1 country4 target enrollmentMay 29, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Uterine Contractions; Prolonged
Sponsor
Fudan University
Enrollment
4
Locations
1
Primary Endpoint
The performance of this system in extracting fetal electrocardiogram (FECG)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
May 29, 2023
End Date
August 6, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hao Li

Principal Investigator

Fudan University

Eligibility Criteria

Inclusion Criteria

  • Pregnant women with a gestational cycle greater than 36 weeks

Exclusion Criteria

  • Pregnant women with a gestational cycle less than 36 weeks

Outcomes

Primary Outcomes

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

Time Frame: 2022.01-2023.08

extract fetal QRS intervals and numbers from FECG

The performance of this system in extracting electrohysterography (EHG)

Time Frame: 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.

Study Sites (1)

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