Clinical Trial

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

Study acronym: PregnaDigit EU
Enrolling by Invitation
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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.
Trial Details
NCT Number NCT07191236
Lead Sponsor UMC Utrecht
Conditions Telemedicine, Digital Health, Pregnancy Complications
Enrollment 450 participants
Start Date 2025-02-17
Primary Completion 2028-02-29 (estimated)
Study Completion 2028-02-29 (estimated)
Updated on ClinicalTrials.gov 2025-09-24