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

Recruiting now

Conditions studied: Validation

In brief

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.

Key facts

Study ID
NCT06683170
Run by
Anna Axelin
People needed
35
Starts
2026-06-05
Expected to finish
2026-09-01
Last updated by the study team
2026-06-22

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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