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

Anna Axelin

Status: Not yet enrolling

Conditions: Validation

Study type: Observational

Funder types: Other

Identifiers

NCT06683170

VARHA/12935/13.02.02/2024

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

35 participants in 2 patient groups

Pregnant women

Description:

Pregnant women wearing the pregnancy monitoring belt for two hours. In addition, the hospital patient monitor will be used to measure mother ECG, heart rate, breathing rate, oxygen saturation, blood pressure, contractions and fetal heart rate and movements.

Healthcare professionals

Description:

Healthcare professionals participating in the pregnancy care.