Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
NCT ID: NCT06683170
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
35 participants
OBSERVATIONAL
2026-02-28
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility Study: Continuous Fetal Monitoring During Maternal Exercise
NCT07077109
Blind Measurement in Fetal Weight Estimation
NCT06687239
Pulse and Constitution of Pregnant Women
NCT05428878
Validation of Pulsewave Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
NCT02823873
Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
NCT04419051
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Healthcare professionals
Healthcare professionals participating in the pregnancy care.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* single pregnancy
* age at least 18 years
* being a healthcare professional working with pregnant women
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Anna Axelin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anna Axelin
Professor
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VARHA/12935/13.02.02/2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.