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Enrolling by Invitation

NCT Number: NCT05763069

HOME: 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.

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Key information

Conditions

Hypertensive Disorder of Pregnancy Female Urogenital Diseases and Pregnancy Complications High Risk Pregnancy Hypertension, Pregnancy-Induced Infections Pre-Eclampsia Preeclampsia Pregnancy Complications Premature Preterm Rupture of Membranes Previous Adverse Obstetric Outcome Toxemia Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. User acceptability of home monitoring

    Time frame: 2022-2035

    Patient expectations (prior to intervention) and reported acceptability and quality of life

  2. Clinical safety of home monitoring

    Time frame: 2022-2035

    Non-inferior compared to patients not undergoing home monitoring ("controls")

  3. Health economics of home monitoring

    Time frame: 2022-2035

    Non-inferior compared to health economics in patients not undergoing home monitoring ("controls")

  4. 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?

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study title

The HOME Study: Home Monitoring of High-risk Pregnancies

Important dates

Study start
2022
Primary completion
2035
Study completion
2040
First posted
Mar 10, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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