Can Conventional ECG Technology Capture Fetal Cardiac Activity?
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
June 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 18, 2024
January 1, 2024
8 years
April 7, 2017
January 16, 2024
Conditions
Keywords
Outcome Measures
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.
12 months
Study Arms (1)
Holter device
OTHERHolter device to be attached to a Singleton or twin pregnant women at 32 weeks gestation to full term
Interventions
Eligibility Criteria
You may qualify if:
- Singleton or twin pregnant women at 32 weeks gestation to full term after routine antepartum testing.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Duke Universitycollaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98105, United States
Related Publications (1)
Efficient fetal-maternal ECG signal separation from two channel maternal abdominal ECG via diffusion-based channel selection Ruilin Li, Martin G. Frasch, Hau-tieng Wu (Submitted on 7 Feb 2017) There is a need for affordable, widely deployable maternal-fetal ECG monitors to improve maternal and fetal health during pregnancy and delivery. Based on the diffusion-based channel selection, here we present the mathematical formalism and clinical validation of an algorithm capable of accurate separation of maternal and fetal ECG from a two channel signal acquired over maternal abdomen. Subjects: Medical Physics (physics.med-ph); Data Analysis, Statistics and Probability (physics.data-an); Applications (stat.AP); Machine Learning (stat.ML) Cite as: arXiv:1702.02025 [physics.med-ph]
BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Martin G Frasch, MD, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor, Obstetrics and Gynecology
Study Record Dates
First Submitted
April 7, 2017
First Posted
April 12, 2017
Study Start
June 2, 2017
Primary Completion
June 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share