Blood pressure checker Withings BPM Pro 2 in pregnancy
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
Run by Withings · NCT07595016 · Data updated 2026-11-12
This study tests whether the Withings BPM Pro 2 blood pressure monitor gives accurate readings for pregnant people, including those with high blood pressure or preeclampsia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Withings Industry-sponsored |
| Locations | 1 site (Yerevan, Armenia) |
| Status | Recruiting |
| Started | May 11, 2026 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07595016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 in the second or third trimester of pregnancy, with normal, high, or preeclamptic BP, and with arm circumference between 22 cm and 42 cm who can provide informed consent and attend the site in Yerevan.
✕Probably not a fit
Patients with conditions preventing accurate BP measurement by cuff, such as certain arm injuries or implanted electrical devices, may not benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the accuracy of the automatic oscillometric Withings BPM Pro 2 device when used on pregnant participants in the second or third trimester. Participants will include individuals who are normotensive, hypertensive, or have preeclampsia, and will undergo BP measurements as part of the protocol. The study focuses on brachial BP readings and aims to validate the device against standard measurements in this population. Eligible participants must be adults with a single arm suitable for cuff placement, able to consent, and followed at the site in Yerevan, Armenia. Data collection will assess measurement accuracy and device reliability in the target group.
Why it matters
Potential benefit: If successful, the device could offer a reliable at-home or clinical BP monitoring option for pregnant patients, potentially supporting better blood pressure management.
How similar studies have gone: Previous validation efforts for BP devices in pregnancy have shown mixed results; this study aims to provide specific validation data for the BPM Pro 2 in this population.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
N2
Yerevan, Armenia, Armenia Recruiting
Study contacts
- Study coordinator: Inès Bedouda
- Email: clinical-trials@withings.com
- Phone: 0141460460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.