High Risk Pregnancy, Hypertensive Disorder of Pregnancy, Preeclampsia, Premature Preterm Rupture of Membranes, Previous Adverse Obstetric Outcome
Conditions
Brief 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 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.
Interventions
OTHERHome surveillance of pregnancies at risk
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.
Sponsors
Oslo University Hospital
University of Oslo
Norwegian SIDS and Stillbirth Society
University of Oxford
Rigshospitalet, Denmark
Sykehuspartner
Dignio
Medexa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Home monitoring of high-risk pregnancies | 2022-2035 | Development of secure data transfer systems from home to electronic patient records at the hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User acceptability of home monitoring | 2022-2035 | Patient expectations (prior to intervention) and reported acceptability and quality of life |
| Clinical safety of home monitoring | 2022-2035 | Non-inferior compared to patients not undergoing home monitoring ("controls") |
| Health economics of home monitoring | 2022-2035 | Non-inferior compared to health economics in patients not undergoing home monitoring ("controls") |
| Placenta-associated biomarkers: improving CTG prediction of adverse outcomes? | 2023-2035 | Do placenta-associateed circulating biomarkers prior to delivery, used in an algoritm, improve CTG-assisted prediction of fetal asphyxia? |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORAnne Cathrine Staff, MD, PhD
Oslo University Hospital
Outcome results
None listed