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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06683170

Enrollment

Registered

2024-11-12

Start date

2026-06-05

Completion date

2026-09-01

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
fetal heart rate	Two hour data collection	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).

Countries

Finland

Contacts

CONTACTSusanna Likitalo

smliki@utu.fi+358405652818

CONTACTAnni Pakarinen

ankorh@utu.fi+358504409740

Outcome results