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

Anna Axelin

Status: Completed

Conditions: Fetal Heart Rate Tracing

Study type: Observational

Funder types: Other

Identifiers

NCT06683183

VARHA/12937/13.02.02/2024

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

11 participants in 1 patient group

Pregnant women

Description:

Pregnant women will wear the set of wearables (chest band, smart watch and arm band) for 15 minutes. In addition, pregnant woman's ECG and fetal heart rate will be measured with hospital's patient monitor.