Can Conventional ECG Technology Capture Fetal Cardiac Activity?
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT03111173
- Status
- Recruiting
Conditions
- Fetal Monitoring
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Holter Device — DEVICEMyECG E3.80 Holter Recorder
Study Details
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.
Key Dates
- Start date
- Jun 2, 2017
- Status verified
- Jan 2024
- Primary completion
- Jun 30, 2025
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DEVICE_FEASIBILITY
Arms
- Other: Holter deviceHolter device to be attached to a Singleton or twin pregnant women at 32 weeks gestation to full term
Primary Outcome Measure
Successful extraction of fetal ECG from the maternal abdominal ECG signal [ Time Frame: 12 months ]
Central Contacts
- Martin G Frasch, MD, PhD206-543-5892
- Amy Gest, MPA206-359-1961
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | Martin Frasch, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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