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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

35 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Anna Axelin

Lead sponsor

University of Turku

Sponsor institution