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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05763069
Other study ID # 473099
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 21, 2022
Est. completion date September 2040

Study information

Verified date April 2024
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (8)

Lead Sponsor Collaborator
Oslo University Hospital Dignio, Medexa, Norwegian SIDS and Stillbirth Society, Rigshospitalet, Denmark, Sykehuspartner, University of Oslo, University of Oxford

Country where clinical trial is conducted

Norway, 

Outcome

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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