Ability of the Polar Wearables to Detect Fetal Heart Rate - Pilot Clinical Study

Completed

• Conditions: Fetal Heart Rate Tracing

• Registration Number: NCT06683183
• Lead Sponsor: Anna Axelin

Brief Summary

The aim of this clinical pilot study is

1. to evaluate the ability of the wearables to detect fetal heart rate

2. to evaluate the ability to distinguish the fetal ECG from the ECG of the mother

The participating pregnant women will wear the Polar wearables (chest band, smart watch, arm band) for 15 minutes during of which, the data will be collected with all three wearables and patient monitor (reference device). The data from the wearables will be compared with the patient monitor data referred as golden standard. Background information will be collected with questionnaires from the participants. The data collection will be conducted in hospital environment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Study Start: 2025-02-19
• Primary Completion: 2025-04-11
• Study Completion: 2025-04-11
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal heart rate	15 minute data collection

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland