Work

Telemonitoring for high-risk pregnancies (PregnaDigit EU): an international hybrid type 2 study protocol

Year: 2026

Type: article

Abstract: Introduction Healthcare systems worldwide are under increasing pressure from workforce shortages, rising costs and growing demands for care. Obstetric care is also affected because high-risk pregnancies require frequent in-hospital monitoring. This strains the healthcare system and reduces the quality of life for patients. Telemonitoring offers a promising solution by shifting care from hospital to home, thereby addressing these demands without compromising care quality. Despite demonstrated benefits, implementation remains limited due to challenges not anticipated in controlled research settings. Aiming to facilitate international implementation of telemonitoring as the new standard of care, we established the PregnaDigit EU consortium. In this consortium, we investigate clinical outcomes, patient experience, healthcare consumption and implementation of telemonitoring in high-risk pregnancies across four European hospitals. Ultimately, our goal is to ensure that pregnancy care remains accessible to all while reducing pressure on the healthcare system. Methods and analysis This multicentre, prospective, hybrid type 2 implementation study is performed at four tertiary centres in three European countries: University Medical Centre Utrecht and Erasmus Medical Centre Rotterdam in the Netherlands, Vall d’Hebron University Hospital in Spain and Karolinska University Hospital in Sweden. This study design allows for the simultaneous evaluation of clinical and implementation outcomes of telemonitoring. Eligible participants are ≥18 years with a singleton pregnancy and gestational age of at least 24+0 weeks requiring frequent cardiotocography (CTG) monitoring for a high-risk pregnancy according to local protocols. The telemonitoring care pathway comprises self-recorded home CTG and blood pressure measurements, which are reviewed by trained professionals who provide same-day feedback and clinical management via teleconsultation. Additionally, the care pathway includes standardised outpatient care and additional assessments, such as ultrasounds and laboratory testing, per local protocol. The primary clinical outcome is a composite of adverse perinatal and maternal events. Secondary clinical outcomes include all individual components of the primary clinical outcome, additional adverse perinatal events and healthcare consumption outcomes. The primary implementation outcomes are assessed using the taxonomy of Proctor et al during three sequential phases: pre-implementation, implementation and post implementation. In the post implementation phase, care pathways before and after telemonitoring implementation are mapped using Metro maps as the foundation for a Time-Driven Activity-Based Costing analysis. For data analysis, clinical outcomes are summarised by descriptive statistics. Implementation outcomes are compared across countries and inclusion groups, which are reported as relative risks with 95% CIs. A p value <0.05 is considered statistically significant. Ethics and dissemination Ethical approval was waived in the Netherlands following an independent quality assessment in the University Medical Centre Utrecht. In the Vall d’Hebron University Hospital, the study protocol was approved by the Ethics Committee (PR(AMI)455/2024). In Karolinska University Hospital, the study protocol was approved by the Swedish Ethical Review Authority (2024–08685-02/2024-04982-01/2025-01056-02). Trial registration number NCT07191236.

Source: BMJ Open

DOI: 10.1136/bmjopen-2025-115566