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Enrolling by invitation NCT05763069

HOME: Home Monitoring of High-risk Pregnancies

Observational Hypertensive Disorder of Pregnancy Premature Preterm Rupture of Membranes Preeclampsia High Risk Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home surveillance of pregnancies at risk.
Who it may be relevant to
Registry conditions: Hypertensive Disorder of Pregnancy, Premature Preterm Rupture of Membranes, Preeclampsia, High Risk Pregnancy. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The HOME Study: Home Monitoring of High-risk Pregnancies

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility of Home monitoring of high-risk pregnancies [Time frame: 2022-2035]
Secondary outcome measures (4)
  • User acceptability of home monitoring [Time frame: 2022-2035]
  • Clinical safety of home monitoring [Time frame: 2022-2035]
  • Health economics of home monitoring [Time frame: 2022-2035]
  • Placenta-associated biomarkers: improving CTG prediction of adverse outcomes? [Time frame: 2023-2035]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Publications

  • 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

Identifiers

NCT: NCT05763069 · 473099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗