TelemedicinePregnaDigit EUNCT07191236
Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care
An observational study of Telemedicine and Digital Health, run by UMC Utrecht at 4 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Telemedicine, Digital Health, Pregnancy Complications
- How many people
- 450 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 17 Feb 2025to 29 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Netherlands2 sites
Erasmus Medical Center Rotterdam (EMC)
Rotterdam, South Holland, 3015 GD
University Medical Center Utrecht (UMCU)
Utrecht, 3584 CX
Spain1 site
Catalan health institute: Vall d'Hebron University Hospital & Vall d'Hebron Research Institute (VHIR)
Barcelona, Catalonia, 08035
Sweden1 site
Region Stockholm: Karolinska Institutet
Stockholm, Stockholm County, 17177
About this study
Official title: Telemonitoring for High-risk Pregnancies in an International Context (PregnaDigit EU): a Hybrid Type 2 Study
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.
Read the detailed description
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.
- Conditions
- Telemedicine, Digital Health, Pregnancy Complications
- Keywords
- Telemedicine, Digital Health, Pregnancy, Pregnant People, Pregnancy Complications, Implementation science
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: During pregnancy up to six months postpartum
Clinical outcome: Adverse perinatal event: Umbilical Cord Prolapse
Measured: During pregnancy and labour
Clinical outcome: Adverse perinatal event: Intrauterine infection requiring antibiotic treatment
Measured: During pregnancy up to six months postpartum
Clinical outcome: Healthcare consumption
Number of days each participant received telemonitoring, as a proxy for the duration of in-hospital admission or outpatient visits potentially avoided. Additionally, number and indications of unplanned hospital visits and admissions.
Measured: During telemonitoring: average 11 days during pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start17 Feb 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireille Bekker, UMC Utrecht
- Investigators
- Martine Depmann, Dr., Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191236
- Sponsor's protocol ID
- OBS_24U-1738
- Other IDs
- 240036
- Acronym
- PregnaDigit EU
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39873168Proctor 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.
PubMed 20957426Bekker 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.
PubMed 36828605
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring for High-risk Pregnancies in an International Context (PregnaDigit EU): a Hybrid Type 2 Study
- ClinicalTrials.gov ID
- NCT07191236
- Acronym / sponsor ID
- PregnaDigit EU / OBS_24U-1738
- Conditions
- Telemedicine, Digital Health, Pregnancy Complications
- Keywords
- Telemedicine, Digital Health, Pregnancy, Pregnant People, Pregnancy Complications, Implementation science
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcome: composite of adverse perinatal and maternal events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Clinical outcome: All individual components of the primary, composite outcome
Time frame: During pregnancy up to six months postpartum
Clinical outcome: Adverse perinatal event: Umbilical Cord Prolapse
Time frame: During pregnancy and labour
Clinical outcome: Adverse perinatal event: Intrauterine infection requiring antibiotic treatment
Time frame: During pregnancy up to six months postpartum
Clinical outcome: Healthcare consumption
Time frame: During telemonitoring: average 11 days during pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 39873168Bekker 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.
- Background: PubMed 20957426Proctor 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.
- Background: PubMed 36828605Bekker 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.
- European Perinatal Health Report: Core indicators of the health and care of pregnant women and babies in Europe from 2015 to 2019.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martine Depmann, Dr. study chair
UMC Utrecht
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telemedicine and Digital Health, run by UMC Utrecht at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome: composite of adverse perinatal and maternal events (time frame: During pregnancy up to six months postpartum). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07191236, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.