The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06031142
Recruitment Status : Completed
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Hao Li, Fudan University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Uterine Contractions; Prolonged Fetal Heart Rate or Rhythm Abnormality Affecting Fetus Pregnancy Related Home Range 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 4 participants
Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.
Actual Study Start Date : May 29, 2023
Actual Primary Completion Date : July 29, 2023
Actual Study Completion Date : August 6, 2023
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • 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.
    Other Names:
    • Non-invasive monitoring
    • FECG
    • EHG

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The performance of this system in extracting fetal electrocardiogram (FECG) [ Time Frame: 2022.01-2023.08 ]
    extract fetal QRS intervals and numbers from FECG

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031142


Locations
Layout table for location information
China, Pudong New District， Shanghai
FetaCare
Shanghai, Pudong New District， Shanghai, China, 200100
Sponsors and Collaborators
Fudan University
Investigators
Layout table for investigator information
Principal Investigator: Tingting Li, master Fudan University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hao Li, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT06031142    
Other Study ID Numbers: PROFE23186I
2022YFB4400800 ( Other Grant/Funding Number: the National Key R&D Program of China )
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hao Li, Fudan University:
FECG
EHG
Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Abnormalities