HOME: Home Monitoring of High-risk Pregnancies

NCT ID: NCT05763069

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-21

Study Completion Date

2040-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Norwegian SIDS and Stillbirth Society

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Sykehuspartner

UNKNOWN

Sponsor Role collaborator

Dignio

UNKNOWN

Sponsor Role collaborator

Medexa

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Cathrine Staff

Professor, Head of research, MD; PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Cathrine Staff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 40726590 (View on PubMed)

Other Identifiers

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473099

Identifier Type: -

Identifier Source: org_study_id

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