Can Conventional ECG Technology Capture Fetal Cardiac Activity?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can Conventional ECG Technology Capture Fetal Cardiac Activity?

Conditions
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Fetal Monitoring

Intervention / Treatment
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* Device: Holter Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton or twin pregnant women at 32 weeks gestation to full term after routine antepartum testing. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Fetus, R peak extraction