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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Norwegian SIDS and Stillbirth Society | OTHER |
| University of Oxford | OTHER |
| Rigshospitalet, Denmark |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home surveillance of pregnancies at risk | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| User acceptability of home monitoring | Patient expectations (prior to intervention) and reported acceptability and quality of life | 2022-2035 |
| Clinical safety of home monitoring | Non-inferior compared to patients not undergoing home monitoring ("controls") |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Anne Cathrine Staff, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40726590 | Derived | 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. |
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Pending on patient consent and ethical approval details
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| ID | Term |
|---|---|
| D014115 | Toxemia |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
| Sykehuspartner | UNKNOWN |
| Dignio | UNKNOWN |
| Medexa | UNKNOWN |
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| 2022-2035 |
| Health economics of home monitoring | Non-inferior compared to health economics in patients not undergoing home monitoring ("controls") | 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? | 2023-2035 |
| D000091642 | Urogenital Diseases |