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ENROLLING BY INVITATION
NCT07191236

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

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

Summary

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.

Official title: Telemonitoring for High-risk Pregnancies in an International Context (PregnaDigit EU): a Hybrid Type 2 Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

450

Start Date

2025-02-17

Completion Date

2028-02-29

Last Updated

2025-09-24

Healthy Volunteers

No

Locations (4)

Erasmus Medical Center Rotterdam (EMC)

Rotterdam, South Holland, Netherlands

University Medical Center Utrecht (UMCU)

Utrecht, Netherlands

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

Barcelona, Catalonia, Spain

Region Stockholm: Karolinska Institutet

Stockholm, Stockholm County, Sweden