ValidationNCT06683170
Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
An observational study of Validation, run by Anna Axelin at 1 site in Finland.
Trial summary
The aims of this clinical pilot study are to: 1. to validate the following parameters: mother heart rate, mother ECG, fetal heart rate, contractions, mother oxygen saturation, mother breathing rate, mother blood pressure 2. to evaluate the feasibility on detecting fetal movements 3. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Validation
- How many people
- 35 participants
- Where
- 1 siteFinland
- Study dates
- 5 Jun 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 will be recruited from different units participating in pregnancy care: maternity clinics, pregnancy outpatient clinic and pregnancy follow-up ward. The monitoring during the data collection will not affect the normal pregnancy monitoring practices. The recruitment will be conducted via social media. The healthcare professionals will be recruited also from different units in the area of Wellbeing services county of Southwest Finland: pregnancy follow-up ward, labour ward, maternity outpatient clinic and maternity clinics. The recruitment will be conducted via work email.
Who may be able to join
- duration pf pregnancy at least 29+0 weeks
- single pregnancy
- age at least 18 years
- ability to participate in Finnish No exclusion criteria
- being a healthcare professional working with pregnant women
- being able to participate in Finnish No exclusion criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku
Anna Axelin, Professor, +358405029905, anmaax@utu.fi
About this study
The aims of this clinical pilot study are to:
- to validate the following parameters: mother heart rate, mother ECG, fetal heart rate, contractions, mother oxygen saturation, mother breathing rate, mother blood pressure
- to evaluate the feasibility on detecting fetal movements
- to explore how pregnant women and health care professionals perceive the acceptability and usability of the pregnancy monitoring system
- to explore the possibility to support prenatal attachment between parent and fetus with remote pregnancy monitoring
The participating pregnant women will wear the pregnancy monitoring belt for 2 hours during of which, the data will be collected with pregnancy monitoring belt and patient monitor (reference device). The data from the pregnancy monitoring belt will be compared with the patient monitor data referred as golden standard. The acceptability and usability will be assessed by pregnant women and healthcare professionals by fulfilling a questionnaire and participating in interviews. The data collection will be conducted in hospital environment.
- Conditions
- Validation
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 wearing the pregnancy monitoring belt for two hours. In addition, the hospital patient monitor will be used to measure mother ECG, heart rate, breathing rate, oxygen saturation, blood pressure, contractions and fetal heart rate and movements. | |
| Healthcare professionals | Healthcare professionals participating in the pregnancy care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fetal heart rate
Fetal heart rate will be measured with the sensorized pregnancy monitoring belt and to evaluate the accuracy of the measurements, the fetal heart rate measurements will be compared with the hospital patient monitor (golden standard).
Measured: Two hour 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 start5 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValidationStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Axelin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Axelin, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683170
- Sponsor's protocol ID
- VARHA/12935/13.02.02/2024
- Status last verified
- Jun 2026
- First submitted
- 8 Nov 2024
- Last updated
- 22 Jun 2026
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT06683170
- Acronym / sponsor ID
- VARHA/12935/13.02.02/2024
- Conditions
- Validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Anna AxelinUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- 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 aims of this clinical pilot study are to:
- to validate the following parameters: mother heart rate, mother ECG, fetal heart rate, contractions, mother oxygen saturation, mother breathing rate, mother blood pressure
- to evaluate the feasibility on detecting fetal movements
- to explore how pregnant women and health care professionals perceive the acceptability and usability of the pregnancy monitoring system
- to explore the possibility to support prenatal attachment between parent and fetus with remote pregnancy monitoring
The participating pregnant women will wear the pregnancy monitoring belt for 2 hours during of which, the data will be collected with pregnancy monitoring belt and patient monitor (reference device). The data from the pregnancy monitoring belt will be compared with the patient monitor data referred as golden standard. The acceptability and usability will be assessed by pregnant women and healthcare professionals by fulfilling a questionnaire and participating in interviews. The data collection will be conducted in hospital environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women wearing the pregnancy monitoring belt for two hours. In addition, the hospital patient monitor will be used to measure mother ECG, heart rate, breathing rate, oxygen saturation, blood pressure, contractions and fetal heart rate and movements. |
| Healthcare professionals | – | –Healthcare professionals participating in the pregnancy care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women will be recruited from different units participating in pregnancy care: maternity clinics, pregnancy outpatient clinic and pregnancy follow-up ward. The monitoring during the data collection will not affect the normal pregnancy monitoring practices. The recruitment will be conducted via social media. The healthcare professionals will be recruited also from different units in the area of Wellbeing services county of Southwest Finland: pregnancy follow-up ward, labour ward, maternity outpatient clinic and maternity clinics. The recruitment will be conducted via work email.
Key inclusion criteria (6 listed)
- duration pf pregnancy at least 29+0 weeks
- single pregnancy
- age at least 18 years
- ability to participate in Finnish No exclusion criteria
- being a healthcare professional working with pregnant women
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: Two hour data collection
Fetal heart rate will be measured with the sensorized pregnancy monitoring belt and to evaluate the accuracy of the measurements, the fetal heart rate measurements will be compared with the hospital patient monitor (golden standard).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Validation, 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 6 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanna Likitalo (+358405652818, smliki@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fetal heart rate (time frame: Two hour 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 22 Jun 2026.