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Clinical Trials/NCT06683183
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

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

  1. to evaluate the ability of the wearables to detect fetal heart rate
  2. 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.

Registry
clinicaltrials.gov
Start Date
February 19, 2025
End Date
April 11, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Anna Axelin
Responsible Party
Sponsor Investigator
Principal Investigator

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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