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

NCT07191236 | Enrolling By Invitation

• 2 other identifiers: OBS_24U-1738240036
• Study Type: observational
• Target: 450
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Telemedicine; Digital Health; Pregnancy Complications

Keywords

Telemedicine; Digital Health; Pregnancy; Pregnant People; Pregnancy Complications; Implementation science

Outcome Measures

Primary Outcomes (9)

• Clinical outcome: composite of adverse perinatal and maternal events

  The primary clinical outcome is a composite measure of adverse perinatal and maternal events. This dichotomous composite is defined as the occurrence of one or more of the following: * Perinatal mortality (maternal, fetal, or neonatal) * Low neonatal condition at birth: 5-minute Apgar score \< 7 and/or arterial cord blood pH \< 7.05 * Maternal morbidity, including one or more of: Hypertensive crisis requiring intravenous antihypertensive medication and/or MgSO4 for eclampsia prevention Eclampsia (new-onset, generalized tonic-clonic seizures or coma in a woman with preeclampsia) HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) Venous thromboembolism (deep vein thrombosis or pulmonary embolism) Maternal admission to an Intensive Care Unit (ICU) Admission of the newborn to a Neonatal Intensive Care Unit (NICU) ≥ 24 hours -Caesarean section.

  During pregnancy up to six months postpartum

• Implementation outcome: Proctor Acceptability

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Acceptability: The perception that telemonitoring is agreeable, palatable or satisfactory among obstetric healthcare providers and pregnant participants. Assessment method is by questionnaires.

  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

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Adoption: The intention to start telemonitoring among obstetric healthcare providers. Assessment method: qualitative analysis of semi-structured interviews and questionnaire.

  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

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Appropriateness: The perceived fit, relevance, or compatibility of telemonitoring among obstetric healthcare providers and pregnant participants.. Assessment method: questionnaire.

  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

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Costs: The cost impact analysis of telemonitoring. Assessment method: Metro Maps and Time Driven Activity Based Costing (TDABC)

  Whole study duration up untill the end of data analysis Feb 2028

• Implementation outcome: Proctor Feasibility

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Feasibility: The extent to which telemonitoring can be successfully used or carried out within the hospital by obstetric healthcare providers. Assessment method is by questionnaires.

  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

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Fidelity: The extent to which telemonitoring is implemented as it was described in the original protocol. Assessment method: Number of wrongful inclusions, eligbile patients missed, adherence to the predefined protocol.

  Whole study duration up untill the end of data analysis Feb 2028

• Implementation outcome: Proctor Penetration

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Penetration: The integration of telemonitoring in the hospital. Assessment method by questionnaire.

  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

  Implementation outcomes will be analyzed according to the taxonomy of Proctor et al. Proctor defined eight implementation outcomes: acceptability, adoption, appropriateness, feasibility, fidelity, costs, penetration and sustainability. Sustainability:The extent to which the use of telemonitoring is maintained within the hospital during and after the implementation phase. Assessment method: questionnaire and the percentage of centers that continued with telemonitoring after the implementation phase.

  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

Secondary Outcomes (4)

• Clinical outcome: All individual components of the primary, composite outcome

  During pregnancy up to six months postpartum

• Clinical outcome: Adverse perinatal event: Umbilical Cord Prolapse

  During pregnancy and labour

• Clinical outcome: Adverse perinatal event: Intrauterine infection requiring antibiotic treatment

  During pregnancy up to six months postpartum

• Clinical outcome: Healthcare consumption

  During telemonitoring: average 11 days during pregnancy

Study Arms (1)

Telemonitoring cohort

This prospective cohort consists of pregnant individuals with high-risk complications who require frequent cardiotocography (CTG) monitoring according to local protocol. Instead of receiving in-hospital CTG monitoring, participants will perform CTG recordings at home, with optional blood pressure (BP) measurements. Recordings are transmitted securely and reviewed by trained obstetric healthcare providers, followed by telephone or video contact. This cohort represents real-world implementation of remote digital pregnancy care and enables evaluation of clinical and implementation outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at four European university hospitals: University Medical Center Utrecht (UMCU) (Netherlands), Erasmus Medical Center (EMC) Rotterdam (Netherlands), Vall d'Hebron University Hospital (Spain), and Karolinska University Hospital (Sweden). The study population consists of pregnant individuals receiving care for high-risk pregnancies that require frequent cardiotocography (CTG) monitoring according to local clinical protocols. Instead of hospital-based monitoring, eligible participants will perform CTG recordings from home using telemonitoring systems.

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (4)

Erasmus Medical Center Rotterdam (EMC)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

University Medical Center Utrecht (UMCU)

Utrecht, 3584 CX, Netherlands

Location

Catalan health institute: Vall d'Hebron University Hospital & Vall d'Hebron Research Institute (VHIR)

Barcelona, Catalonia, 08035, Spain

Location

Region Stockholm: Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• European Perinatal Health Report: Core indicators of the health and care of pregnant women and babies in Europe from 2015 to 2019.

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Martine Depmann, Dr.

  UMC Utrecht

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 24, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); ES (1); NL (2)