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Can a smart cuff catch Pre-Eclampsia early?

NCT ID NCT07595016

Diagnosis Sponsor: Withings Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether the Withings BPM Pro 2, an automatic blood pressure cuff, gives accurate readings for pregnant women, including those with high blood pressure or pre-eclampsia. About 45 participants will have their blood pressure measured with both the device and a standard manual cuff. If accurate, it could offer a convenient way to monitor blood pressure at home during pregnancy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Withings BPM Pro 2 blood pressure monitor
What this could lead to
If successful, this could confirm that the Withings BPM Pro 2 is a reliable home blood pressure monitor for pregnant women, helping detect pre-eclampsia early.
What could go wrong
This is a small validation study (45 people) focused on accuracy, not treatment. It may not reflect real-world use or work for all arm sizes or conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Pre-eclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • N2

    RECRUITING

    Yerevan, Armenia, 0002, Armenia

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