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

NCT ID: NCT06031142

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-29

Study Completion Date

2023-08-06

Brief Summary

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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.

Detailed Description

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

Conditions

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

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Non-invasive monitoring FECG EHG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Hao Li

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tingting Li, master

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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FetaCare

Shanghai, Pudong New District, Shanghai, China

Site Status

Countries

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China

Other Identifiers

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2022YFB4400800

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PROFE23186I

Identifier Type: -

Identifier Source: org_study_id

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