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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Monitoring
• Intervention / Treatment: Device: Holter 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin G Frasch, MD, PhD; Phone Number: 206-543-5892; Email: mfrasch@uw.edu
• Study Contact Backup: Name: Amy Gest, MPA; Phone Number: 206-359-1961; Email: agest@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • University of Washington
      • Principal Investigator: Martin Frasch, MD, PhD
      • Contact: Martin G Frasch, MD, PhD; Phone Number: 206-543-5892; Email: mfrasch@uw.edu
      • Contact: Amy Gest, MPA; Phone Number: 206-359-1961; Email: agest@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Holter device; Holter device to be attached to a Singleton or twin pregnant women at 32 weeks gestation to full term	Device: Holter Device; MyECG E3.80 Holter Recorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Duke University
• Investigators: Principal Investigator: Martin G Frasch, MD, PhD, University of Washington

Publications and helpful links

General Publications

• 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]

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ECG; Fetus; R peak extraction
• Other Study ID Numbers: STUDY00001556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No