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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Validation

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Susanna Likitalo; Phone Number: +358405652818; Email: smliki@utu.fi
• Study Contact Backup: Name: Anni Pakarinen; Phone Number: +358504409740; Email: ankorh@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women will be recruited from different units participating in pregnancy care: maternity clinics, pregnancy outpatient clinic and pregnancy follow-up ward. The monitoring during the data collection will not affect the normal pregnancy monitoring practices. The recruitment will be conducted via social media.

The healthcare professionals will be recruited also from different units in the area of Wellbeing services county of Southwest Finland: pregnancy follow-up ward, labour ward, maternity outpatient clinic and maternity clinics. The recruitment will be conducted via work email.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pregnant women; 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; Healthcare professionals participating in the pregnancy care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fetal heart rate	Fetal heart rate will be measured with the sensorized pregnancy monitoring belt and to evaluate the accuracy of the measurements, the fetal heart rate measurements will be compared with the hospital patient monitor (golden standard).	Two hour data collection

Collaborators and Investigators

• Sponsor: Anna Axelin

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VARHA/12935/13.02.02/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No