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

April 17, 2025 updated by: Anna Axelin

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women recruited for the study are registered at the hospital ward for pregnant women. The data collection will be conducted after the routine fetal monitoring and will not affect normal monitoring practices.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fetal heart rate
Time Frame: 15 minute data collection
15 minute data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Axelin

Collaborators

Polar Electro Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2025

Primary Completion (Actual)

April 11, 2025

Study Completion (Actual)

April 11, 2025

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VARHA/12937/13.02.02/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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