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Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study

Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study

Recruiting
Female
Phase N/A

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Overview

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. to explore how pregnant women and health care professionals perceive the acceptability and usability of the pregnancy monitoring system
  4. 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.

Eligibility

Inclusion criteria for pregnant women:

  • duration pf pregnancy at least 29+0 weeks
  • single pregnancy
  • age at least 18 years
  • ability to participate in Finnish No exclusion criteria

Inclusion criteria for healthcare professionals:

  • being a healthcare professional working with pregnant women
  • being able to participate in Finnish No exclusion criteria

Study details
    Validation

NCT06683170

Anna Axelin

27 June 2026

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