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Can Conventional ECG Technology Capture Fetal Cardiac Activity?

Can Conventional ECG Technology Capture Fetal Cardiac Activity?

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03111173
Enrollment
50
Registered
2017-04-12
Start date
2017-06-02
Completion date
2026-12-31
Last updated
2024-01-18

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

Conditions

Fetal Monitoring

Keywords

ECG, Fetus, R peak extraction

Brief summary

This is a feasibility study for a new application for capturing fetal cardiac activity. The objective of this study is to determine if it is feasible to capture a fetal ECG signal using a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR) device.

Detailed description

The objective of this study is to determine if it is feasible to capture a fetal ECG signal using a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR) device. To obtain the raw FHR data from this standard device we will use the currently approved fetal EEG monitor. The important distinction is that fetal EEG monitor will not be connected to fetal scalp electrode, but, rather, get the data from the regular, more routinely used and non-invasive Doppler FHR monitor. We expect that we will be able to validate our algorithm with our maternal and fetal ECG channels to derive the FHR. We will attach a Holter ECG device (4 electrodes) and a standard Doppler FHR device to a pregnant woman who is between 32 weeks gestation and full term. ECG leads will be placed in four corners of the abdomen. The targeted length of the recording will be 30 minutes. The subject will remain supine and resting while the device is recording. Additionally, the recently approved fetal EEG monitor will be connected to the Doppler FHR device to allow us to obtain a digital copy of the standard FHR recording. We will do that in order to have the comparison during the offline processing of the abdominal ECG with regard to the location of the fetal R peaks. This procedure will be done after the subject's routine antepartum testing. No women in active labor will be recruited.

Interventions

MyECG E3.80 Holter Recorder

Sponsors

Duke University
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Singleton or twin pregnant women at 32 weeks gestation to full term after routine antepartum testing.

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Successful extraction of fetal ECG from the maternal abdominal ECG signal12 monthsWe will test the quality of correct identification of fetal R peaks of ECG from within maternal ECG signal by comparing the R-R-periods-derived instantaneous fetal heart rate (FHR) to the values determined by the standard-of-care ultrasound-derived FHR monitor.

Countries

United States

Contacts

Primary ContactMartin G Frasch, MD, PhD
mfrasch@uw.edu206-543-5892
Backup ContactAmy Gest, MPA
agest@uw.edu206-359-1961

Outcome results

None listed

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