Can Conventional ECG Technology Capture Fetal Cardiac Activity?

Fetal Monitoring Clinical Trial

Official title:

Can Conventional ECG Technology Capture Fetal Cardiac Activity?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03111173
• Other study ID #: STUDY00001556
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2017
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: University of Washington
• Contact: Martin G Frasch, MD, PhD
• Phone: 206-543-5892
• Email: mfrasch[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Fetal Monitoring

Intervention

Device:
• Holter Device
MyECG E3.80 Holter Recorder

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Efficient fetal-maternal ECG signal separation from two channel maternal abdominal ECG via diffusion-based channel selection Ruilin Li, Martin G. Frasch, Hau-tieng Wu (Submitted on 7 Feb 2017) There is a need for affordable, widely deployable maternal-fetal ECG monitors to improve maternal and fetal health during pregnancy and delivery. Based on the diffusion-based channel selection, here we present the mathematical formalism and clinical validation of an algorithm capable of accurate separation of maternal and fetal ECG from a two channel signal acquired over maternal abdomen. Subjects: Medical Physics (physics.med-ph); Data Analysis, Statistics and Probability (physics.data-an); Applications (stat.AP); Machine Learning (stat.ML) Cite as: arXiv:1702.02025 [physics.med-ph]

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful extraction of fetal ECG from the maternal abdominal ECG signal	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.	12 months

External Links

•   Efficient fetal-maternal ECG signal separation from two channel maternal abdominal ECG via diffusion-based channel selection