Preeclampsia Clinical Trial
Official title:
The HOME Study: Home Monitoring of High-risk Pregnancies
Verified date | April 2024 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Enrolling by invitation |
Enrollment | 224 |
Est. completion date | September 2040 |
Est. primary completion date | September 2035 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Preeclampsia - Gestational Hypertension - Premature Preterm Rupture of Membranes - High Risk Pregnancy - Previous adverse obstetric outcomes Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Dignio, Medexa, Norwegian SIDS and Stillbirth Society, Rigshospitalet, Denmark, Sykehuspartner, University of Oslo, University of Oxford |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Home monitoring of high-risk pregnancies | Development of secure data transfer systems from home to electronic patient records at the hospital | 2022-2035 | |
Secondary | User acceptability of home monitoring | Patient expectations (prior to intervention) and reported acceptability and quality of life | 2022-2035 | |
Secondary | Clinical safety of home monitoring | Non-inferior compared to patients not undergoing home monitoring ("controls") | 2022-2035 | |
Secondary | Health economics of home monitoring | Non-inferior compared to health economics in patients not undergoing home monitoring ("controls") | 2022-2035 | |
Secondary | 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? | 2023-2035 |
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