An observational study in Validation, sponsored by Anna Axelin. Recruiting at 1 site in Finland. Open to female participants. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Anna Axelin · Observational
The aims of this clinical pilot study are to:
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.
Anna Axelin is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion criteria for pregnant women:
Inclusion criteria for healthcare professionals:
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 participating in the pregnancy care.
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).
Time frame: Two hour data collection
Plan to share: Undecided
No publications or documents are linked to this record.
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