NCT06683170

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: Anna Axelin · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Validation

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-11-12
• Last updated: 2026-01-13