HOME: Home Monitoring of High-risk Pregnancies

NCT05763069 | Enrolling By Invitation

• 1 other identifier: 473099
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• User acceptability of home monitoring

  2022-2035

• Clinical safety of home monitoring

  2022-2035

• Health economics of home monitoring

  2022-2035

• Placenta-associated biomarkers: improving CTG prediction of adverse outcomes?

  2023-2035

Interventions

Home surveillance of pregnancies at risk OTHER

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• Preeclampsia
• Gestational Hypertension
• Premature Preterm Rupture of Membranes
• High Risk Pregnancy
• Previous adverse obstetric outcomes

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: collaborator
• Rigshospitalet, Denmark: collaborator
• Dignio: collaborator
• Medexa: collaborator
• Oslo University Hospital: lead
• University of Oslo: collaborator
• Norwegian SIDS and Stillbirth Society: collaborator
• Sykehuspartner: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

• Waldum AH, Pay ASD, Aasbo G, Mishra VK, Sugulle M, Staff AC. The HOME (home monitoring of high-risk pregnancies) study: a study protocol for an observational study of a telemedicine-assisted follow-up at home vs. hospitalization. Front Glob Womens Health. 2025 Jul 14;6:1599153. doi: 10.3389/fgwh.2025.1599153. eCollection 2025.

  PMID: 40726590 DERIVED

MeSH Terms

Conditions

Toxemia; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Infections; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anne Cathrine Staff, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of research, MD; PhD

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: November 21, 2022
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2040
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

NO (1)