Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
ConditionValidation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorAnna Axelin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
duration pf pregnancy at least 29+0 weeks
single pregnancy
age at least 18 years
ability to participate in Finnish No
Disqualifiers
being a healthcare professional working with pregnant women
being able to participate in Finnish No exclusion criteria
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
35 Participants
are grouped into 2 trial groupsGroup A: Pregnant women
Group B: Healthcare professionals
Trial outcomes
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).
Time frame
Two hour data collectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anna Axelin
Lead sponsor
University of Turku
Sponsor institution
Source ClinicalTrials.gov