Recruiting
Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
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
ClinicalTrials.gov IDNCT07595016
PhaseNA
Enrollment45
SponsorWithings
Age18 Years and older
SexALL
Conditions studied
Hypertension, Pre-eclampsia
About this study
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
Interventions
- Device: Blood pressure measurement — The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)
Primary outcomes
- Blood pressure measurement performace evaluation per measure (5 months)
Eligibility information
Inclusion Criteria:
* 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 Criteria:
* 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.
Study locations
- N2, Yerevan, Armenia 0002 Armenia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.