Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT03969433
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-05-28', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy and reliability in the detection of foetal heart rate', 'timeFrame': "Throughout the subject's participation in the study, from inclusion until delivery", 'description': 'Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference'}, {'measure': 'Accuracy and reliability in the detection of foetal movements', 'timeFrame': "Throughout the subject's participation in the study, from inclusion until delivery", 'description': 'Foetal movements are detected from the collected sensor data and compared to the reference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Foetal Wellbeing']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.\n\nData is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.\n\nThe collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.\n\nClinical information related to subjects' pregnancy and foetal health is also collected."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant\n* Gestational age of at least 20 weeks\n* Singleton pregnancy\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Implanted pacemaker or any other implanted electrical device\n* History of allergies to silicone-based adhesives'}, 'identificationModule': {'nctId': 'NCT03969433', 'briefTitle': 'Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bloom Technologies'}, 'officialTitle': 'Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring', 'orgStudyIdInfo': {'id': 'BEATLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I', 'description': 'Data collections are performed with TMSi Porti system and CTG (reference)', 'interventionNames': ['Device: TMSi Porti']}, {'type': 'EXPERIMENTAL', 'label': 'Phases II-III-IV', 'description': 'Data collections are performed with the Bloomlife sensor and CTG (reference)', 'interventionNames': ['Device: Bloomlife sensor']}], 'interventions': [{'name': 'TMSi Porti', 'type': 'DEVICE', 'description': 'Data collections', 'armGroupLabels': ['Phase I']}, {'name': 'Bloomlife sensor', 'type': 'DEVICE', 'description': 'Data collections', 'armGroupLabels': ['Phases II-III-IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'overallOfficials': [{'name': 'Wilfried Gyselaers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Oost-Limburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bloom Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}