Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-31 @ 8:15 AM
Study NCT ID:
NCT05054504
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2021-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of Butterfly iQ
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The primary intervention under study is the Butterfly iQ ultrasound, embedded in a larger program of training, iterative service delivery design, and a final program evaluation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1575}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2021-09-04', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gestational age at first ANC contact', 'timeFrame': '7 months', 'description': 'Median gestational age at first ANC contact'}, {'measure': 'Number and types of suspected and confirmed higher-risk conditions identified by ultrasound and recorded in study records', 'timeFrame': '7 months', 'description': 'Numbers of the following\n\n* Ectopic pregnancy\n* Multiple gestation\n* Abnormal placentation\n* Intrauterine fetal demise\n* Abnormalities of amniotic fluid, e.g., oligohydramnios, polyhydramnios\n* Fetal anomaly\n* Other condition not specified above'}], 'primaryOutcomes': [{'measure': 'Feasibility of the intervention by participant report', 'timeFrame': '7 months', 'description': 'Proportion of enrolled midwives who report the intervention to be feasible'}, {'measure': 'Feasibility of the intervention by quality standards met (ultrasound)', 'timeFrame': '7 months', 'description': 'Proportion of ultrasound examinations found to meet quality standards'}, {'measure': 'Feasibility of the intervention by quality standards met (ANC)', 'timeFrame': '7 months', 'description': 'Proportion of ANC visits (that included Butterfly IQ) found to meet quality standards'}, {'measure': 'Feasibility of the intervention by observation of functioning systems', 'timeFrame': '7 months', 'description': 'Proportion of Butterfly IQ systems functioning at end of study period'}, {'measure': 'Feasibility of the intervention by observation of environments of care', 'timeFrame': '7 months', 'description': 'Proportion of participating HC with facilitative environments of care'}], 'secondaryOutcomes': [{'measure': 'Acceptability, by participant report (providers)', 'timeFrame': '7 months', 'description': 'Proportion of providers who find the intervention acceptable'}, {'measure': 'Acceptability, by participant report (ANC clients)', 'timeFrame': '7 months', 'description': 'Proportion of ANC clients who find the intervention acceptable'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Butterfly IQ', 'Malawi', 'Blantyre', 'Antenatal care', 'ANC/PNC Research Collective', 'Point of care ultrasound', 'Bill & Melinda Gates Foundation', 'Johns Hopkins Research Project', 'Johns Hopkins Bloomberg School of Public Health'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate feasibility and acceptability of a novel intervention to integrate Butterfly IQ into antenatal care (ANC) service delivery in Malawi. The study will also explore potential impact of the intervention on selected service delivery outcomes and identification of abnormal pregnancies.', 'detailedDescription': 'The purpose of this study is to investigate the feasibility and acceptability of a novel intervention to integrate Butterfly IQ into ANC service delivery in Blantyre, Malawi. This study will further the understanding of antenatal ultrasound in Malawi by testing the following hypothesis:\n\nWhen planned and implemented collaboratively with local stakeholders, limited introduction and integration of point-of-care ultrasound with Butterfly iQ into ANC service delivery at health center level will be feasible and acceptable for health providers and clients.\n\nThe study intervention will include a multi-phased approach to design, introduction, improvement, and evaluation of Butterfly IQ for routine obstetric ultrasound integrated into ANC service delivery in Malawi.\n\nPhase 1: Training Phase 1 includes training on Butterfly IQ, integration in ANC workflow, and referral/counter-referral within network.\n\nPhase 2: Iterative Service Delivery Phase 2 includes weekly evaluation and iterative re-design of services.\n\nPhase 3: Final Evaluation Phase 3 includes evaluation for potential integration into current policies and frameworks; determination to pursue pending additional factors; or determination of incompatibility, as well as selected support for transition/handover, if applicable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility criteria by phase and participant type\n\nPhase 1 Inclusion Criteria\n\n1. Member of HC or hospital staff providing obstetric care.\n2. Able and willing to comply with all study requirements and complete all study procedures.\n3. Able and willing to provide informed consent to be screened for and to take part in the study.\n\nPhase 1 Exclusion Criteria 1. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n\nPhase 2 Inclusion Criteria\n\nStudy Participant - Health Center and Hospital Staff:\n\n1. Member of HC or hospital staff providing obstetric care.\n2. Able and willing to comply with all study requirements and complete all study procedures.\n3. Able and willing to provide informed consent to be screened for and to take part in the study.\n\nStudy Participant - ANC Clients:\n\nParticipants must meet all criteria to be eligible for inclusion in the study:\n\n1. Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs).\n2. At enrollment, present for first ANC visit.\n3. Able and willing to comply with all study requirements and complete all Phase 2 study procedures.\n4. Able and willing to provide informed consent to be screened for and to take part in Phase 2 of the study.\n5. Intention to stay within study catchment area for study Phase 2 duration and willingness to give adequate locator information, as defined in site SOPs.\n\nPhase 2 Exclusion Criteria\n\nStudy Participant - Health Center and Hospital Staff:\n\n1\\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n\nStudy participant - ANC Clients:\n\n1\\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives\n\nPhase 3 Inclusion Criteria\n\n1. Participated in Phase 1 or 2 of the study or newly recruited stakeholder interested in development or implementation of obstetric ultrasound in Malawi.\n2. Able and willing to comply with all study requirements and complete all Phase 3 study procedures.\n3. Able and willing to provide informed consent to be screened for and to take part in Phase 3 of the study.\n\nPhase 3 Exclusion Criteria\n\n1\\. Has any condition that, in the opinion of the investigator/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives'}, 'identificationModule': {'nctId': 'NCT05054504', 'acronym': 'FAB-IQ', 'briefTitle': 'Feasibility and Acceptability of Butterfly iQ', 'organization': {'class': 'OTHER', 'fullName': 'Jhpiego'}, 'officialTitle': 'Integration of Butterfly iQ Point of Care Ultrasound Into Antenatal Care in Blantyre, Malawi: A Feasibility and Acceptability Study', 'orgStudyIdInfo': {'id': 'ARC-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'The primary intervention is a multi-phase, mixed methods, implementation research study that will investigate the feasibility and acceptability of the limited introduction of ultrasound via the Butterfly iQ device into routine ANC service delivery at health center level in Blantyre, Malawi. The study will occur in three phases: 1) Training, 2) Iterative Service Delivery, and 3) Final Evaluation.', 'interventionNames': ['Device: Butterfly iQ']}], 'interventions': [{'name': 'Butterfly iQ', 'type': 'DEVICE', 'description': 'The primary intervention under study is the Butterfly iQ point-of-care ultrasound device, embedded in a larger program of training, iterative ANC service delivery design, and a final program evaluation.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Johns Hopkins Research Project', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Lisa M Noguchi, PhD, MSN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jhpiego, Johns Hopkins University'}, {'name': 'Linly Seyama', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malawi College of Medicine, JHP Blantyre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jhpiego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, {'name': 'Kamuzu University of Health Sciences', 'class': 'OTHER'}, {'name': 'Ministry of Health, Malawi', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}