Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-eclampsia

NCT07595016 | Recruiting

• 1 other identifier: 2026-A00642-49
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Pre-eclampsia

Keywords

hypertension; blood pressure monitor; pregnancy; pre-eclampsia; validation

Outcome Measures

Primary Outcomes (1)

• Blood pressure measurement performace evaluation per measure

  The blood pressure (systolic and diastolic blood pressure) measurement performance will be established using the mean value of the differences and the standard deviation between the device under study and the reference for each measure.

  5 months

Study Arms (1)

All patients

EXPERIMENTAL

Patients consenting to participate to the study and compliant to the inclusion criteria

Device: Blood pressure measurement

Interventions

Blood pressure measurement DEVICE

The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Withings: lead

Study Sites (1)

N2

Yerevan, Armenia, 0002, Armenia

RECRUITING

MeSH Terms

Conditions

Hypertension; Pre-Eclampsia

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Central Study Contacts

Inès Bedouda

CONTACT

0141460460; clinical-trials@withings.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)