Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03111173

Can Conventional ECG Technology Capture Fetal Cardiac Activity?

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

Holter Device

Device

MyECG E3.80 Holter Recorder

Primary outcomes

  1. Successful extraction of fetal ECG from the maternal abdominal ECG signal

    Time frame: 12 months

    We 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Gest, MPA

CONTACT

[email protected]

206-359-1961

Martin G Frasch, MD, PhD

CONTACT

[email protected]

206-543-5892

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Duke University

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Apr 12, 2017
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.