HOME: Home Monitoring of High-risk Pregnancies

February 13, 2026 updated by: Anne Cathrine Staff, Oslo University Hospital

The HOME Study: Home Monitoring of High-risk Pregnancies

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women identified with the at-risk pregnancies described above, attending Oslo University Hospital's Department of Obstetrics (some controls will also be recruited at another South-Eastern Norway Dept of Obstetrics, at Drammen hospital).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Home monitoring of high-risk pregnancies
Time Frame: 2022-2035
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
Time Frame: 2022-2035
Patient expectations (prior to intervention) and reported acceptability and quality of life
2022-2035
Clinical safety of home monitoring
Time Frame: 2022-2035
Non-inferior compared to patients not undergoing home monitoring ("controls")
2022-2035
Health economics of home monitoring
Time Frame: 2022-2035
Non-inferior compared to health economics in patients not undergoing home monitoring ("controls")
2022-2035
Placenta-associated biomarkers: improving CTG prediction of adverse outcomes?
Time Frame: 2023-2035
Do placenta-associateed circulating biomarkers prior to delivery, used in an algoritm, improve CTG-assisted prediction of fetal asphyxia?
2023-2035

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo
Rigshospitalet, Denmark
University of Oxford
Norwegian SIDS and Stillbirth Society
Sykehuspartner
Dignio
Medexa

Investigators

  • Principal Investigator: Anne Cathrine Staff, MD, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2022

Primary Completion (Estimated)

September 1, 2035

Study Completion (Estimated)

September 1, 2040

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 473099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Pending on patient consent and ethical approval details

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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