Actively Recruiting
Clinical Validation of the Withings BPM Pro 2 Blood Pressure Device in Pregnancy and Pre-Eclampsia According to Universal Protocol by AAMI/ESH/ISO
Led by Withings · Updated on 2026-06-03
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of the Withings BPM Pro 2, an automatic oscillometric blood pressure measuring device used at the arm level, specifically in pregnant women and those with pre-eclampsia. The study aims to validate this device according to the Universal Protocol for Blood Pressure Measuring Devices by leading medical organizations. It includes participants who are pregnant in their second or third trimester, with varying blood pressure conditions including normotension, hypertension, or pre-eclampsia. Participants will have their blood pressure measured alternately using a standard reference mercury sphygmomanometer (four times) and the Withings BPM Pro 2 device (three times). This process is applied to all patients consenting and meeting the inclusion criteria. The study does not involve blinding or multiple arms beyond this device evaluation. During the five-month study period, participants will undergo these blood pressure measurements to assess the device's performance. Researchers will monitor blood pressure results carefully to determine accuracy compared to the reference method. Participants must have an arm circumference between 22 cm and 42 cm and be followed at the study site either as in-patient or out-patient. The study ensures ongoing safety by excluding patients with certain medical conditions or inability to consent.
CONDITIONS
Brief Title
Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 18 years
- Pregnant in second or third trimester (more than 3 months)
- Patient is normotensive, hypertensive, or has pre-eclampsia
- Signed informed consent form
- Followed at study site as in-patient or out-patient
- Arm circumference between 22 cm and 42 cm
You will not qualify if you...
- Unable to give consent or understand study information
- Suffering from arrhythmia
- Poor quality Korotkov sounds
- Absence of K5 Korotkov sounds
- Wearing implantable electric medical device (e.g., pacemaker)
- Open wounds or damaged skin on both upper arms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 months
Participants undergo blood pressure measurements using both a reference mercury sphygmomanometer and the Withings BPM Pro 2 device to validate accuracy.
Multiple measurement visits over the study period
Trial Site Locations
Total: 1 location
1
N2
Yerevan, Armenia, Armenia, 0002
Actively Recruiting
Research Team
I
Inès Bedouda
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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