HOME: Home Monitoring of High-risk Pregnancies

Study Overview
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Brief Summary
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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.

Official Title
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The HOME Study: Home Monitoring of High-risk Pregnancies

Conditions
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Premature Preterm Rupture of Membranes, Preeclampsia, Hypertensive Disorder of Pregnancy, High Risk Pregnancy, Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: Home surveillance of pregnancies at risk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preeclampsia Gestational Hypertension Premature Preterm Rupture of Membranes High Risk Pregnancy Gestational Diabetes Mellitus 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Home 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |