Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
Recruiting · NCT07595016 · Interventional (participants receive a specific treatment) · Lead sponsor: Withings
View the official record on ClinicalTrials.gov →Interventions studied
Blood pressure measurement
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →