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

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT06031142
Collaborator
(none)
4
Enrollment
1
Location
2.3
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
4 participants
Observational Model:
Family-Based
Time Perspective:
Prospective
Official Title:
Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.
Actual Study Start Date :
May 29, 2023
Actual Primary Completion Date :
Jul 29, 2023
Actual Study Completion Date :
Aug 6, 2023

Outcome Measures

Primary Outcome Measures

  1. The performance of this system in extracting fetal electrocardiogram (FECG) [2022.01-2023.08]

    extract fetal QRS intervals and numbers from FECG

  2. The performance of this system in extracting electrohysterography (EHG) [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

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 FetaCare Shanghai Pudong New District， Shanghai China 200100

Sponsors and Collaborators

  • Fudan University

Investigators

  • Principal Investigator: Tingting Li, master, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hao Li, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier:
NCT06031142
Other Study ID Numbers:
  • PROFE23186I
  • 2022YFB4400800
First Posted:
Sep 11, 2023
Last Update Posted:
Sep 11, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hao Li, Principal Investigator, Fudan University
FECG
EHG
Additional relevant MeSH terms:
Congenital Abnormalities

Study Results

No Results Posted as of Sep 11, 2023