HOME: Home Monitoring of High-risk Pregnancies

Preeclampsia Clinical Trial

Official title:

The HOME Study: Home Monitoring of High-risk Pregnancies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05763069
• Other study ID #: 473099
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• High Risk Pregnancy
• Hypertension
• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Preeclampsia
• Rupture
• Toxemia

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