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NCT Number: NCT06683170

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. fetal heart rate

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Anni Pakarinen

CONTACT

[email protected]

+358504409740

Susanna Likitalo

CONTACT

[email protected]

+358405652818

Sponsors and collaborators

Lead sponsor

Anna Axelin

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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