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

Pregnancy Related Clinical Trial

— AHTSWFEADP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031142
• Other study ID #: PROFE23186I
• Secondary ID: 2022YFB4400800
• Status: Completed
• Start date: May 29, 2023
• Est. completion date: August 6, 2023

Study information

• Verified date: September 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 6, 2023
• Est. primary completion date: July 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
• Pregnancy Related

Intervention

Device:
• use wearable devices to monitoring fetal health conditions.
We used wearable devices and clinical cardiotocography (CTG) equipment to monitor pregnant women for 30 minutes to demonstrate the reliability of wearable devices.

Locations

Country	Name	City	State
China	FetaCare	Shanghai	Pudong New District, Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The performance of this system in extracting fetal electrocardiogram (FECG)	extract fetal QRS intervals and numbers from FECG	2022.01-2023.08
Primary	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