A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy

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.

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Key information

Conditions

Uterine Contractions; Prolonged Behavior Behavior, Animal Fetal Heart Rate or Rhythm Abnormality Affecting Fetus Home Range Homing Behavior Pregnancy Related

Sex eligibility

Female

Study type

Observational

Primary location

FetaCare

Shanghai, Pudong New District， Shanghai, 200100, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant women with a gestational cycle greater than 36 weeks

Exclusion criteria

male
Pregnant women with a gestational cycle less than 36 weeks

Treatment and study plan

use wearable devices to monitoring fetal health conditions.

Device

We used wearable devices and clinical cardiotocography (CTG) equipment to monitor pregnant women for 30 minutes to demonstrate the reliability of wearable devices.

Other names: Non-invasive monitoring, FECG, EHG

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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: AHTSWFEADP

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Sep 11, 2023
Registry last updated: Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed