HOME: Home Monitoring of High-risk Pregnancies

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05763069
• Collaborator: University of Oslo (Other), Norwegian SIDS and Stillbirth Society (Other), University of Oxford (Other), Rigshospitalet, Denmark (Other), Sykehuspartner (Other), Dignio (Other), Medexa (Other)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 213.4
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertensive Disorder of Pregnancy; Premature Preterm Rupture of Membranes; Preeclampsia; High Risk Pregnancy; Diabetes Mellitus in Pregnancy	Other: Home surveillance of pregnancies at risk

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The HOME Study: Home Monitoring of High-risk Pregnancies
• Actual Study Start Date: Nov 21, 2022
• Anticipated Primary Completion Date: Sep 1, 2035
• Anticipated Study Completion Date: Sep 1, 2040

Outcome Measures

Primary Outcome Measures

1. Feasibility of Home monitoring of high-risk pregnancies [2022-2035]

   Development of secure data transfer systems from home to electronic patient records at the hospital

Secondary Outcome Measures

1. User acceptability of home monitoring [2022-2035]

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

2. Clinical safety of home monitoring [2022-2035]

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

3. Health economics of home monitoring [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? [2023-2035]

   Do placenta-associateed circulating biomarkers prior to delivery, used in an algoritm, improve CTG-assisted prediction of fetal asphyxia?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Preeclampsia

• Gestational Hypertension

• Premature Preterm Rupture of Membranes

• High Risk Pregnancy

• Gestational Diabetes Mellitus

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0424

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne Cathrine Staff, Professor, Head of research, MD; PhD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT05763069
• Other Study ID Numbers: 473099
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Toxemia; Pre-Eclampsia; Pregnancy in Diabetics; Fetal Membranes, Premature Rupture; Hypertension; Rupture

Study Results

No Results Posted as of Mar 10, 2023