Hypertensive Disorder of PregnancyNCT05763069
HOME: Home Monitoring of High-risk Pregnancies
An observational study of Hypertensive Disorder of Pregnancy and Premature Preterm Rupture of Membranes, run by Oslo University Hospital at 1 site in Norway.
Trial summary
High-risk pregnancies often require long-term hospitalization or outpatient maternal and/or fetal monitoring, placing a burden on patients, hospital resources and society. The demand for intensified pregnancy surveillance and interventions is increasing, due to the increased prevalence of risk factors like obesity and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Premature Preterm Rupture of Membranes, Preeclampsia
- What is being tested?
- Home surveillance of pregnancies at risk
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 21 Nov 2022to Sep 2040
- How long will I take part?
- 5 Months
- Phase
- Observational
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women identified with the at-risk pregnancies described above, attending Oslo University Hospital's Department of Obstetrics (some controls will also be recruited at another South-Eastern Norway Dept of Obstetrics, at Drammen hospital).
Who may be able to join
- Preeclampsia
- Gestational Hypertension
- Premature Preterm Rupture of Membranes
- High Risk Pregnancy
- Previous adverse obstetric outcomes
Who cannot join
- Multiples (twins, triplets etc)
- Patient or fetus in immediate need for delivery
- Not understanding Norwegian
- Not mastering the technological aspects of home monitoring
- Long travel distance to Obstetric Department
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The HOME Study: Home Monitoring of High-risk Pregnancies
High-risk pregnancies often require long-term hospitalization or outpatient maternal and/or fetal monitoring, placing a burden on patients, hospital resources and society. The demand for intensified pregnancy surveillance and interventions is increasing, due to the increased prevalence of risk factors like obesity and advanced maternal age, as well as altered guidelines resulting in increasing labor induction rates.The main aims of the HOME study (Home monitoring of pregnancies at risk) are to assess if home monitoring of selected high-risk pregnancies for maternal and fetal wellbeing is feasible, safe (in a clinical trial), cost-efficient, and simultaneously empowers the users.
- Conditions
- Hypertensive Disorder of Pregnancy, Premature Preterm Rupture of Membranes, Preeclampsia, High Risk Pregnancy, Previous Adverse Obstetric Outcome
- Being tested
- Home surveillance of pregnancies at risk
- Medical subject headings
- Toxemia, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home surveillance of pregnancies at riskOther
Offer women with pregnancies at risk home surveillance instaed of more frequent hospital out-patient visits and/or hospitalisation: cardiotocographia (CTG), patient measurements of CRP, temperature, blood pressure, and clinical signs of infection or severe forms of preeclampsia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Home monitoring of high-risk pregnancies
Development of secure data transfer systems from home to electronic patient records at the hospital
Measured: 2022-2035
Secondary outcomes (4)
User acceptability of home monitoring
Patient expectations (prior to intervention) and reported acceptability and quality of life
Measured: 2022-2035
Clinical safety of home monitoring
Non-inferior compared to patients not undergoing home monitoring ("controls")
Measured: 2022-2035
Health economics of home monitoring
Non-inferior compared to health economics in patients not undergoing home monitoring ("controls")
Measured: 2022-2035
Placenta-associated biomarkers: improving CTG prediction of adverse outcomes?
Do placenta-associateed circulating biomarkers prior to delivery, used in an algoritm, improve CTG-assisted prediction of fetal asphyxia?
Measured: 2023-2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start21 Nov 2022
- Primary completionSep 2035 (estimated)
- Study completionSep 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 250 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian SIDS and Stillbirth Society, University of Oxford, Copenhagen University Hospital, Rigshospitalet, Sykehuspartner, Dignio, Medexa
- Responsible party
- Principal investigator, Anne Cathrine Staff, Oslo University Hospital
- Investigators
- Anne Cathrine Staff, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763069
- Sponsor's protocol ID
- 473099
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending on patient consent and ethical approval details
Publications
Waldum AH, Pay ASD, Aasbo G, Mishra VK, Sugulle M, Staff AC. The HOME (home monitoring of high-risk pregnancies) study: a study protocol for an observational study of a telemedicine-assisted follow-up at home vs. hospitalization. Front Glob Womens Health. 2025 Jul 14;6:1599153. doi: 10.3389/fgwh.2025.1599153. eCollection 2025.
PubMed 40726590