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

NCT06683170 | Not Yet Recruiting

• 1 other identifier: VARHA/12935/13.02.02/2024
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of this clinical pilot study are to:

1. 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. 2.to evaluate the feasibility on detecting fetal movements
3. 3.to explore how pregnant women and health care professionals perceive the acceptability and usability of the pregnancy monitoring system
4. 4.to explore the possibility to support prenatal attachment between parent and fetus with remote pregnancy monitoring

Conditions

Validation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• duration pf pregnancy at least 29+0 weeks
• single pregnancy
• age at least 18 years

You may not qualify if:

• being a healthcare professional working with pregnant women

Sponsors & Collaborators

• Anna Axelin: lead

Central Study Contacts

Susanna Likitalo

CONTACT

+358405652818; smliki@utu.fi

Anni Pakarinen

CONTACT

+358504409740; ankorh@utu.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01