Can Conventional ECG Technology Capture Fetal Cardiac Activity?
ConditionFetal Monitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton or twin pregnant women at 32 weeks gestation to full term after routine antepartum testing.
Disqualifiers
None.
Trial design
Design model
Single group
Treatments tested in this trial
Holter Device
DeviceMyECG E3.80 Holter Recorder
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Holter deviceOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSponsors and contacts
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University of Washington
Lead sponsor
Duke University
Collaborator
Source ClinicalTrials.gov