Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT04441866
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2020-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of ultrasound examination', 'timeFrame': 'During ultrasound examination', 'description': 'Duration of ultrasound examination in minutes'}], 'secondaryOutcomes': [{'measure': 'Quality score of fetal biometry', 'timeFrame': 'During ultrasound examination', 'description': 'Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)'}, {'measure': 'Quality score of fetal diagnostic planes', 'timeFrame': 'During ultrasound examination', 'description': 'Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best)'}, {'measure': 'Operator satisfaction', 'timeFrame': 'During ultrasound examination', 'description': 'Visual analogue scale: from 0 (worst) to 32 (best)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasonography, Prenatal']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, during the second trimester ultrasound scan.', 'detailedDescription': 'In recent years in many ultrasound equipment were fitted with automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy. Although there are studies that have assessed the application of these algorithms in terms of repeatability of the measurements made, or of possibility of acquiring diagnostic planes, there are no randomized controlled studies that evaluated their impact on the second trimester ultrasound scan.\n\nThe aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, in terms of:\n\n* duration of the ultrasound scan\n* quality of biometric measurements\n* quality of the diagnostic planes\n* operator satisfaction'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy 19+0-21+6 weeks\n* Live fetus\n* No fetal abnormalities\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Intrauterine fetal death\n* Fetal abnormalities'}, 'identificationModule': {'nctId': 'NCT04441866', 'acronym': 'Auto-2T', 'briefTitle': 'Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'officialTitle': 'Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound', 'orgStudyIdInfo': {'id': 'NP3574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Automated algorithms', 'description': 'Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes', 'interventionNames': ['Diagnostic Test: Automated algorithms']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard technique', 'description': 'Standard 2D assessment', 'interventionNames': ['Diagnostic Test: Standard technique']}], 'interventions': [{'name': 'Automated algorithms', 'type': 'DIAGNOSTIC_TEST', 'description': 'Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy', 'armGroupLabels': ['Automated algorithms']}, {'name': 'Standard technique', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy', 'armGroupLabels': ['Standard technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Ciivli', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Federico Prefumo', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}