Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT05763069
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-29
First Post:
2023-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HOME: Home Monitoring of High-risk Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}, 'targetDuration': '5 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2040-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Home monitoring of high-risk pregnancies', 'timeFrame': '2022-2035', 'description': 'Development of secure data transfer systems from home to electronic patient records at the hospital'}], 'secondaryOutcomes': [{'measure': 'User acceptability of home monitoring', 'timeFrame': '2022-2035', 'description': 'Patient expectations (prior to intervention) and reported acceptability and quality of life'}, {'measure': 'Clinical safety of home monitoring', 'timeFrame': '2022-2035', 'description': 'Non-inferior compared to patients not undergoing home monitoring ("controls")'}, {'measure': 'Health economics of home monitoring', 'timeFrame': '2022-2035', 'description': 'Non-inferior compared to health economics in patients not undergoing home monitoring ("controls")'}, {'measure': 'Placenta-associated biomarkers: improving CTG prediction of adverse outcomes?', 'timeFrame': '2023-2035', 'description': 'Do placenta-associateed circulating biomarkers prior to delivery, used in an algoritm, improve CTG-assisted prediction of fetal asphyxia?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertensive Disorder of Pregnancy', 'Premature Preterm Rupture of Membranes', 'Preeclampsia', 'High Risk Pregnancy', 'Previous Adverse Obstetric Outcome']}, 'referencesModule': {'references': [{'pmid': '40726590', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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).", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preeclampsia\n* Gestational Hypertension\n* Premature Preterm Rupture of Membranes\n* High Risk Pregnancy\n* Previous adverse obstetric outcomes\n\nExclusion Criteria:\n\n* Multiples (twins, triplets etc)\n* Patient or fetus in immediate need for delivery\n* Not understanding Norwegian\n* Not mastering the technological aspects of home monitoring\n* Long travel distance to Obstetric Department'}, 'identificationModule': {'nctId': 'NCT05763069', 'briefTitle': 'HOME: Home Monitoring of High-risk Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'The HOME Study: Home Monitoring of High-risk Pregnancies', 'orgStudyIdInfo': {'id': '473099'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Home surveillance of pregnancies at risk', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Anne Cathrine Staff, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Pending on patient consent and ethical approval details'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Norwegian SIDS and Stillbirth Society', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Sykehuspartner', 'class': 'UNKNOWN'}, {'name': 'Dignio', 'class': 'UNKNOWN'}, {'name': 'Medexa', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of research, MD; PhD', 'investigatorFullName': 'Anne Cathrine Staff', 'investigatorAffiliation': 'Oslo University Hospital'}}}}