University of Washington
Seattle, Washington, 98105, United States
Location status: Recruiting
Location contact
Amy Gest, MPA
CONTACT
Martin Frasch, MD, PhD
PRINCIPAL_INVESTIGATOR
Martin G Frasch, MD, PhD
CONTACT
NCT Number: NCT03111173
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.
Interested in participating?
Request Info18 year–55 year
Female
Interventional
Not applicable
Seattle, Washington, 98105, United States
Location status: Recruiting
Amy Gest, MPA
CONTACT
Martin Frasch, MD, PhD
PRINCIPAL_INVESTIGATOR
Martin G Frasch, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MyECG E3.80 Holter Recorder
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.
Contact information is provided by the study sponsor or research team.
Amy Gest, MPA
CONTACT
Martin G Frasch, MD, PhD
CONTACT
University of Washington
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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