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NCT07191236: PregnaDigit EU

Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care

ENROLLING BY INVITATION Last updated 24 September 2025
What this trial tests

trial in Telemedicine in 450 participants. Enrolling by invitation.

Timeline
17 February 2025
Primary endpoint
29 February 2028
29 February 2028

Quick facts

Lead sponsorUMC Utrecht
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment450
Start date17 February 2025
Primary completion29 February 2028
Estimated completion29 February 2028
Sites4 locations across Sweden, Netherlands, Spain

Conditions studied

Sponsor

UMC Utrecht — full company profile →

Who can join

18 and older, female only, with Telemedicine or Digital Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pregnancy care is under increasing pressure due to a rising number of women needing medical care, a shortage of obstetric healthcare professionals, and growing healthcare costs. For women with high-risk pregnancies, this often leads to frequent hospital visits or admissions for monitoring, which can be stressful and time consuming. Remote digital care offers a promising alternative by allowing pregnant individuals to perform monitoring from home while remaining under medical supervision. This study will evaluate the use of telemonitoring in pregnancy care in four European hospitals. Participants with high-risk pregnancies who require frequent cardiotocography (CTG) monitoring and blood pressure (BP) measurements will use certified home devices to record fetal and maternal health data. Instead of hospital-based monitoring, CTG and BP measurements will be performed at home and assessed by trained healthcare professionals. The main purpose of the study is to investigate whether home monitoring is a safe and acceptable alternative to in-hospital monitoring, and to identify what is needed for successful national and international implementation of remote digital pregnancy care. The investigators will collect clinical and implementation outcomes. By doing so, this study aims to keep pregnancy care accessible for all women, improve patient well-being, and reduce pressure on the healthcare system.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Telemedicine

Currently open trials in the same condition.

Other UMC Utrecht trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07191236.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing