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RecruitingNCT07595016WIHYP-PWUpdated Jun 3, 2026

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

An interventional study of Blood pressure measurement in Hypertension and Pre-eclampsia, sponsored by Withings. Recruiting at 1 site in Armenia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Withings · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Hypertension
  • Pre-eclampsia

Keywords

  • hypertension
  • blood pressure monitor
  • pregnancy
  • pre-eclampsia
  • validation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    All patients

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

    Device: Blood pressure measurement

Interventions

  • DeviceBlood pressure measurement

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

05

What researchers measure

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.

    Time frame: 5 months

06

Study locations

1 of 1 sites recruiting
  • N2
    Yerevan, Armenia 0002, Armenia
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07595016
Lead sponsor
Withings
Responsible party
Sponsor
First posted
May 19, 2026
Start date
May 11, 2026
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jun 3, 2026

Study contacts

Inès Bedouda
Contact
clinical-trials@withings.com
0141460460

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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