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Clinical Trials/NCT03111173
NCT03111173
Recruiting
Not Applicable

Can Conventional ECG Technology Capture Fetal Cardiac Activity?

University of Washington1 site in 1 country50 target enrollmentJune 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetal Monitoring
Sponsor
University of Washington
Enrollment
50
Locations
1
Primary Endpoint
Successful extraction of fetal ECG from the maternal abdominal ECG signal
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2, 2017
End Date
December 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martin Frasch

Research Assistant Professor, Obstetrics and Gynecology

University of Washington

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Sites (1)

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