Fetal Heart Rate TracingNCT06683183
Ability of the Polar Wearables to Detect Fetal Heart Rate - Pilot Clinical Study
An observational study of Fetal Heart Rate Tracing, run by Anna Axelin at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Heart Rate Tracing
- How many people
- 11 participants
- Where
- 1 siteFinland
- Study dates
- 19 Feb 2025to 11 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- duration of pregnancy at least 29+0 weeks
- single pregnancy
- age at least 18 years
- ability to participate in Finnish. No exclusion criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fetal Heart Rate Tracing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart rate
Measured: 15 minute data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start19 Feb 2025
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart Rate TracingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Axelin
- Sponsor type
- University, hospital or other
- Collaborators
- Polar Electro Oy
- Responsible party
- Sponsor-investigator, Anna Axelin, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683183
- Sponsor's protocol ID
- VARHA/12937/13.02.02/2024
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of the Polar Wearables to Detect Fetal Heart Rate - Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT06683183
- Acronym / sponsor ID
- VARHA/12937/13.02.02/2024
- Conditions
- Fetal Heart Rate Tracing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Anna AxelinUniversity, hospital or other
- Collaborators
- Polar Electro Oy
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- duration of pregnancy at least 29+0 weeks
- single pregnancy
- age at least 18 years
- ability to participate in Finnish. No exclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal heart rate
Time frame: 15 minute data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Fetal Heart Rate Tracing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Heart Rate Tracing, run by Anna Axelin at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal heart rate (time frame: 15 minute data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.