Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWithings
About this trial
The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in pregnancy and pre-eclampsia
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient older than 18 years;
Known pregnancy, in second or third trimester of pregnancy ( > 3 months);
Patient normotensive, hypertensive or in preeclampsia;
Patient who signed the informed consent form;
Disqualifiers
Patient unable to give a consent or understand properly protocol information;
Patient suffering from arrhythmia;
Patient with poor quality of Korotkov sounds;
Patient for whom K5 sounds are absent;
Trial design
Design model
Single group
Treatments tested in this trial
Blood pressure measurement
DeviceThe patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: All patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood pressure measurement performace evaluation per measure
The blood pressure (systolic and diastolic blood pressure) measurement performance will be established using the mean value of the differences and the standard deviation between the device under study and the reference for each measure.
Time frame
5 months Source ClinicalTrials.gov