Ability of the Polar Wearables to Detect Fetal Heart Rate - Pilot Clinical Study

NCT ID: NCT06683183

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-19

Study Completion Date

2025-04-11

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Heart Rate Tracing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

Pregnant women will wear the set of wearables (chest band, smart watch and arm band) for 15 minutes. In addition, pregnant woman's ECG and fetal heart rate will be measured with hospital's patient monitor.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* duration of pregnancy at least 29+0 weeks
* single pregnancy
* age at least 18 years
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Polar Electro Oy

UNKNOWN

Sponsor Role collaborator

Anna Axelin

OTHER

Sponsor Role lead

Responsible Party

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Anna Axelin

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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VARHA/12937/13.02.02/2024

Identifier Type: -

Identifier Source: org_study_id

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