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

Официальное название

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

Обзор

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.

Подробное описание

This study investigates the implementation and effectiveness of telemonitoring using cardiotocography (CTG) and blood pressure (BP) home monitoring in four European academic hospitals. RDPC allows pregnant individuals with high-risk complications to conduct CTG recordings at home, which are then reviewed by trained obstetric healthcare providers through secure digital platforms. This approach has the potential to replace hospital-based monitoring, reduce healthcare consumption, and improve patient well-being while maintaining safety.

The study is conducted in four tertiary referral centers for obstetric care: University Medical Center Utrecht and Erasmus Medical Center in the Netherlands, Vall d'Hebron University Hospital in Spain, and Karolinska University Hospital in Sweden. These hospitals serve large and diverse populations and have extensive experience with managing high-risk pregnancies, providing an international perspective on the implementation and effectiveness of RDPC.

Telemonitoring will be conducted with CE-certified CTG devices (PregnaBit Pro with PregnaOne Platform or Mosos CTG by ICT/HCTS, or the Nemo fetal monitoring system by Nemo Healthcare), and in some centers, blood pressure will be monitored using Microlife WatchBP devices. All devices are CE-certified and not classified as investigational products in this study.

The study follows a hybrid type 2 implementation-effectiveness design. First, this study will assess clinical outcomes of participants undergoing telemonitoring. The study will investigate adverse maternal and perinatal outcomes to ensure that home monitoring is a safe alternative to hospital-based care. To further assess the clinical effectiveness of telemonitoring, investigators will evaluate health care consumption of pregnant participants during telemonitoring, such as the number of days each participant received telemonitoring and number and indications of unplanned hospital visits and admissions. These data will provide insight into the health care demands associated with the telemonitoring care pathways. These measures will provide valuable insights into the efficiency and scalability of telemonitoring.

In addition to clinical outcomes, this study will evaluate implementation outcomes across three sequential phases: pre-implementation, implementation, and post-implementation. Outcomes are based on the taxonomy of Proctor et al., including acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration, and sustainability. Implementation data will be collected from patients and obstetric healthcare professionals, and hospital systems through questionnaires, interviews, and structured data analyses.

Data will be collected and managed in Castor EDC, a GCP-classified web-based data management platform. Data entry will be performed by local research teams, with centralized oversight and quality assurance procedures. Analyses will include descriptive statistics, logistic regression to evaluate the composite clinical endpoint, and regression models to identify factors influencing implementation success.

Ultimately, this study aims to generate knowledge, recommendations, and scalable care models that enable sustainable nationwide and international integration of remote digital pregnancy care, keeping care accessible while reducing system pressure and costs.

Первичные конечные точки

• Clinical outcome: composite of adverse perinatal and maternal events [Срок оценки: During pregnancy up to six months postpartum]
• Implementation outcome: Proctor Acceptability [Срок оценки: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Questionnaire pregnant participants: 5 days after starting telemonitoring. Depending on each site and participant questionnaires are send out in 2025.]
• Implementation outcome: Proctor Adoption [Срок оценки: Qualitative analysis of semi-structures interviews: pre-implementation phase (dec-jan 2025)Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase (2025).]
• Implementation outcome: Proctor Appropriateness [Срок оценки: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Depending on each site and participant questionnaires are send out in 2025.]
• Implementation outcome: Proctor Costs [Срок оценки: Whole study duration up untill the end of data analysis Feb 2028]
• Implementation outcome: Proctor Feasibility [Срок оценки: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Depending on each site and participant questionnaires are send out in 2025.]
• Implementation outcome: Proctor Fidelity [Срок оценки: Whole study duration up untill the end of data analysis Feb 2028]
• Implementation outcome: Proctor Penetration [Срок оценки: Questionnaire obstetric health care providers: at baseline and at the end of the implementation phase. Depending on each site and participant questionnaires are send out in 2025.]
• Implementation outcome: Proctor Sustainability [Срок оценки: Depending on each site and participant questionnaires are send out in 2025. Percentage: Whole study duration up untill the end of data analysis Feb 2028]

Вторичные конечные точки (4)

• Clinical outcome: All individual components of the primary, composite outcome [Срок оценки: During pregnancy up to six months postpartum]
• Clinical outcome: Adverse perinatal event: Umbilical Cord Prolapse [Срок оценки: During pregnancy and labour]
• Clinical outcome: Adverse perinatal event: Intrauterine infection requiring antibiotic treatment [Срок оценки: During pregnancy up to six months postpartum]
• Clinical outcome: Healthcare consumption [Срок оценки: During telemonitoring: average 11 days during pregnancy]

Критерии участия

Критерии включения

• ≥18 years old
• A singleton pregnancy of ≥26+0 weeks of gestation (UMCU, EMC, and Vall d'Hebron) or ≥24+0 weeks of gestation (Karolinska)
• Able to give informed consent.
• Proficiency in English or the local language (Dutch, Spanish or Swedish)
• The presence of a complication requiring CTG monitoring according to local protocol

Критерии исключения

• Pregnancy complications requiring intravenous (IV) anti-hypertensive therapy
• Expected obstetric intervention within 48 hours
• Current blood pressure ≥160 mmHg systolic or ≥110 mmHg diastolic
• Active antepartum hemorrhage
• CTG abnormalities suggestive of fetal stress or hypoxia
• Residence located more than a 30-minute drive from any hospital (not necessarily the hospital initiating home monitoring)
• Presence of an implanted medical device (e.g. pacemaker)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 2 центра

• Erasmus Medical Center Rotterdam (EMC) — Rotterdam
• University Medical Center Utrecht (UMCU) — Utrecht

Испания · 1 центр

• Catalan health institute: Vall d'Hebron University Hospital & Vall d'Hebron Research Insti — Barcelona

Швеция · 1 центр

• Region Stockholm: Karolinska Institutet — Stockholm

Публикации

• Bekker MN, Stephansson O, Maiz N, van der Kemp M, Ahaus K, Franx A. Digital healthcare as a solution for global challenges: A call for action. Acta Obstet Gynecol Scand. 2025 Feb;104(2):250-252. doi: 10.1111/aogs.15066. Epub 2025 Jan 28. No abstract available. PMID 39873168
• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426
• Bekker MN, Koster MPH, Keusters WR, Ganzevoort W, de Haan-Jebbink JM, Deurloo KL, Seeber L, van der Ham DP, Zuithoff NPA, Frederix GWJ, van den Heuvel JFM, Franx A. Home telemonitoring versus hospital care in complicated pregnancies in the Netherlands: a randomised, controlled non-inferiority trial (HoTeL). Lancet Digit Health. 2023 Mar;5(3):e116-e124. doi: 10.1016/S2589-7500(22)00231-X. PMID 36828605

Идентификаторы

NCT: NCT07191236 · OBS_24U-1738 · 240036

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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