Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Validation. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- fetal heart rate [Time frame: Two hour data collection]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Finland · 1 center
- Turku University Hospital — Turku
Identifiers
NCT: NCT06683170 · VARHA/12935/13.02.02/2024