NCT06683183
Completed
Not Applicable
Ability of the Polar Wearables to Detect Fetal Heart Rate - Pilot Clinical Study
Anna Axelin1 site in 1 country11 target enrollmentFebruary 19, 2025
ConditionsFetal Heart Rate Tracing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fetal Heart Rate Tracing
- Sponsor
- Anna Axelin
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Fetal heart rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of this clinical pilot study is
- to evaluate the ability of the wearables to detect fetal heart rate
- to evaluate the ability to distinguish the fetal ECG from the ECG of the mother
The participating pregnant women will wear the Polar wearables (chest band, smart watch, arm band) for 15 minutes during of which, the data will be collected with all three wearables and patient monitor (reference device). The data from the wearables will be compared with the patient monitor data referred as golden standard. Background information will be collected with questionnaires from the participants. The data collection will be conducted in hospital environment.
Investigators
Anna Axelin
Professor
University of Turku
Eligibility Criteria
Inclusion Criteria
- •duration of pregnancy at least 29+0 weeks
- •single pregnancy
- •age at least 18 years
- •ability to participate in Finnish. No exclusion criteria
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Fetal heart rate
Time Frame: 15 minute data collection
Study Sites (1)
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