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Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care
Sponsor: UMC Utrecht
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