HOME: Home Monitoring of High-risk Pregnancies

• Conditions: Hypertensive Disorder of Pregnancy; Premature Preterm Rupture of Membranes; High Risk Pregnancy; Previous Adverse Obstetric Outcome; Preeclampsia

• Registration Number: NCT05763069
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2035-09
• Study Completion: 2040-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 224

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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?
Health economics of home monitoring	2022-2035	Non-inferior compared to health economics in patients not undergoing home monitoring ("controls")
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")

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway