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

NCT06031142 | Completed

• 2 other identifiers: PROFE23186I2022YFB4400800
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

FECG; EHG

Outcome Measures

Primary Outcomes (2)

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

  extract fetal QRS intervals and numbers from FECG

  2022.01-2023.08

• The performance of this system in extracting electrohysterography (EHG)

  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

Interventions

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.

Also known as: Non-invasive monitoring, FECG, EHG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women with a gestational cycle greater than 36 weeks

You may not qualify if:

• male
• Pregnant women with a gestational cycle less than 36 weeks

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

FetaCare

Shanghai, Pudong New District， Shanghai, 200100, China

Location

MeSH Terms

Conditions

Homing Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Tingting Li, master

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 11, 2023
• Study Start: May 29, 2023
• Primary Completion: July 29, 2023
• Study Completion: August 6, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)