Can Conventional ECG Technology Capture Fetal Cardiac Activity?

NCT ID: NCT03111173

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2026-12-31

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.

Conditions

Fetal Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Holter device

Holter device to be attached to a Singleton or twin pregnant women at 32 weeks gestation to full term

Group Type: OTHER

Holter Device

Intervention Type: DEVICE

MyECG E3.80 Holter Recorder

Interventions

Holter Device

MyECG E3.80 Holter Recorder

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Martin Frasch

Research Assistant Professor, Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin G Frasch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Martin G Frasch, MD, PhD

Role: CONTACT

mfrasch@uw.edu

206-543-5892

Amy Gest, MPA

Role: CONTACT

agest@uw.edu

206-359-1961

Facility Contacts

Martin G Frasch, MD, PhD

Role: primary

mfrasch@uw.edu

206-543-5892

Amy Gest, MPA

Role: backup

agest@uw.edu

206-359-1961

References

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]

Reference Type: BACKGROUND

Related Links

http://journal.frontiersin.org/article/10.3389/fphys.2017.00277/abstract

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

Other Identifiers

STUDY00001556

Identifier Type: -

Identifier Source: org_study_id