Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-eclampsia
CLINICAL VALIDATION OF THE BRACHIAL BLOOD PRESSURE MEASURING DEVICE WITHINGS BPM PRO 2 ACCORDING TO "THE UNIVERSAL PROTOCOL FOR THE VALIDATION OF BLOOD PRESSURE MEASURING DEVICES BY THE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION / EUROPEAN SOCIETY OF HYPERTENSION / INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (AAMI/ESH/ISO) (AND ITS AMENDMENT 1 (2020) AND 2 (2024))" IN PREGNANCY AND PRE-ECLAMPSIA
Withings
45 participants
May 11, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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;
- Patient followed-up at site (in-patient or out-patient);
- Patient with arm circumference between 22 cm and 42 cm.
Exclusion Criteria6
- 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;
- Patient wearing an implantable electric medical device (pacemaker,…);
- Patient with both upper arms suffering from open wound and/or damaged skin.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07595016