Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood pressure measurement.
- Who it may be relevant to
- Registry conditions: Hypertension, Pre-eclampsia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Armenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 outcome measures
- Blood pressure measurement performace evaluation per measure [Time frame: 5 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Armenia · 1 center
- N2 — Yerevan
Identifiers
NCT: NCT07595016 · 2026-A00642-49