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Pregnancy care goes digital: home monitoring trial launches across europe

NCT ID NCT07191236

Disease control Sponsor: UMC Utrecht Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether women with high-risk pregnancies can safely monitor their baby's heart rate and their own blood pressure from home instead of going to the hospital. About 450 participants across four European hospitals will use certified home devices, with data reviewed remotely by healthcare professionals. The goal is to see if home monitoring is a safe, acceptable alternative that reduces stress and healthcare costs.

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.

Participants

About 450 people

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

Started

Feb 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Participants will be recruited at four European university hospitals: University Medical Center Utrecht (UMCU) (Netherlands), Erasmus Medical Center (EMC) Rotterdam (Netherlands), Vall d'Hebron University Hospital (Spain), and Karolinska University Hospital (Sweden). The study population consists of pregnant individuals receiving care for high-risk pregnancies that require frequent cardiotocography (CTG) monitoring according to local clinical protocols. Instead of hospital-based monitoring, eligible participants will perform CTG recordings from home using telemonitoring systems.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * ≥18 years old * A singleton pregnancy of ≥26+0 weeks of gestation (UMCU, EMC, and Vall d'Hebron) or ≥24+0 weeks of gestation (Karolinska) * Able to give informed consent. * Proficiency in English or the local language (Dutch, Spanish or Swedish) * The presence of a complication requiring CTG monitoring according to local protocol Exclusion Criteria: * Pregnancy complications requiring intravenous (IV) anti-hypertensive therapy * Expected obstetric intervention within 48 hours * Current blood pressure ≥160 mmHg systolic or ≥110 mmHg diastolic * Active antepartum hemorrhage * CTG abnormalities suggestive of fetal stress or hypoxia * Residence located more than a 30-minute drive from any hospital (not necessarily the hospital initiating home monitoring) * Presence of an implanted medical device (e.g. pacemaker)

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Conditions

The condition(s) this trial relates to.

pregnancy disorder

As listed by the trial registrant

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

Digital health Pregnancy complications Telemedicine

How to take part

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

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

Locations

  • Catalan health institute: Vall d'Hebron University Hospital & Vall d'Hebron Research Institute (VHIR)

    Barcelona, Catalonia, 08035, Spain

  • Erasmus Medical Center Rotterdam (EMC)

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Region Stockholm: Karolinska Institutet

    Stockholm, Stockholm County, 17177, Sweden

  • University Medical Center Utrecht (UMCU)

    Utrecht, 3584 CX, Netherlands

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