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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥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
Exclusion Criteria:
* 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)
Primary outcome measure(s)
Clinical outcome: composite of adverse perinatal and maternal events — During pregnancy up to six months postpartum 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.
Implementation outcome: Proctor Acceptability — 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 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.
Implementation outcome: Proctor Adoption — 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 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.
Implementation outcome: Proctor Appropriateness — 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 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.
Implementation outcome: Proctor Costs — Whole study duration up untill the end of data analysis Feb 2028 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)
Implementation outcome: Proctor Feasibility — 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 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.
Implementation outcome: Proctor Fidelity — Whole study duration up untill the end of data analysis Feb 2028 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.
Implementation outcome: Proctor Penetration — 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 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.
Implementation outcome: Proctor Sustainability — 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 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.
Trial sites (4)
Facility
City
Region
Status
Erasmus Medical Center Rotterdam (EMC)
Rotterdam
South Holland
University Medical Center Utrecht (UMCU)
Utrecht
Netherlands
Catalan health institute: Vall d'Hebron University Hospital & Vall d'Hebron Research Institute (VHIR)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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