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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06031142
Acronym
AHTSWFEADP
Enrollment
4
Registered
2023-09-11
Start date
2023-05-29
Completion date
2023-08-06
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

FECG, EHG

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.

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.

Interventions

DEVICEuse 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.

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
The performance of this system in extracting fetal electrocardiogram (FECG)2022.01-2023.08extract fetal QRS intervals and numbers from FECG
The performance of this system in extracting electrohysterography (EHG)2022.01-2023.08use the contractions consistency index (CCI) parameters to analyze the relation between our measured EHG signal and the UC signal recorded by clinical CTG equipment.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026