Telemonitoring for high-risk pregnancies (PregnaDigit EU): an international hybrid type 2 study protocol
7 affiliations
- 1Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands
- 2Department of Obstetrics and Gynecology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands
- 3Erasmus School of Health Policy and Management, Department Health Services Management and Organization, Erasmus University Rotterdam, Rotterdam, The Netherlands
- 4Obstetrics Department, Vall d’Hebron University Hospital, Barcelona, Spain
- 5VDKMP Alliance Management, Value Based Healthcare, Clinical Leadership and Care Redesign, Amsterdam, The Netherlands
- 6Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden
- 7Karolinska University Hospital, Stockholm, Sweden
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.
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BibTeX
@article{oorschot2026telemonitoring,
title = {{Telemonitoring for high-risk pregnancies (PregnaDigit EU): an international hybrid type 2 study protocol}},
author = {Hélène Françoise Caroline van Oorschot and Rebecca Vellekoop-van Ravenswaaij and Eline Willemijn W Bel and Kees Ahaus and Ester del Barco and Evelien S Van Hoorn and Michèle Van Der Kemp and Nerea Maiz and Petra Jacintha Porte and Anke G Posthumus and Olof Stephansson and Martine Depmann and Arie Franx and Mireille N Bekker},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2025-115566},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-115566},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Telemonitoring for high-risk pregnancies (PregnaDigit EU): an international hybrid type 2 study protocol
AU - Hélène Françoise Caroline van Oorschot
AU - Rebecca Vellekoop-van Ravenswaaij
AU - Eline Willemijn W Bel
AU - Kees Ahaus
AU - Ester del Barco
AU - Evelien S Van Hoorn
AU - Michèle Van Der Kemp
AU - Nerea Maiz
AU - Petra Jacintha Porte
AU - Anke G Posthumus
AU - Olof Stephansson
AU - Martine Depmann
AU - Arie Franx
AU - Mireille N Bekker
PY - 2026
DA - 2026/10/22
JO - BMJ Open
DO - 10.1136/bmjopen-2025-115566
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-115566
AB - 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.
SN - 2044-6055
SN - 2044-6055
ER -