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

September 3, 2023 updated by: Hao Li, Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: use wearable devices to monitoring fetal health conditions.

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Pudong New District， Shanghai
  - Shanghai, Pudong New District， Shanghai, China, 200100
    - FetaCare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A wearable and remote fetal monitoring system is specifically developed for home use. It aims to overcome the limitations of conventional cardiotocography (CTG) devices by providing great user comfort and long-term continuous monitoring.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The performance of this system in extracting fetal electrocardiogram (FECG) Time Frame: 2022.01-2023.08	extract fetal QRS intervals and numbers from FECG	2022.01-2023.08
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.	2022.01-2023.08

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

Principal Investigator: Tingting Li, master, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Actual)

July 29, 2023

Study Completion (Actual)

August 6, 2023

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)