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NCT Number: NCT07595016

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Pressure Measurement

Device

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

Primary outcomes

  1. Blood pressure measurement performace evaluation per measure

    Time frame: 5 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Inès Bedouda

CONTACT

[email protected]

0141460460

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Official study 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

Acronym: WIHYP-PW

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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