Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT03168932
Status:
UNKNOWN
Last Update Posted:
2017-06-07
First Post:
2017-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of Fetal Brains' Sulci Along Gestation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-05', 'studyFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphological changes of the developing fetal brain', 'timeFrame': '9 months', 'description': 'Ultrasound measurements of the fetal brain sulcation by a computerized algorithm'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Brain Injury']}, 'descriptionModule': {'briefSummary': "Gyrogenesis is an ontogenic process that transforms the smooth (lissencephalic) cortex toward its mature, convolved (gyrencephalic) state. A tortuous, branching and deepening pattern of sulci and fissures outlines for a well-developed cortex.\n\nThe aim of this study is to find an algorithm that can detect the sulci in ultrasound images of fetus' brain and measure the length of it. This algorithm can be used for research demands like learning the development of the brain from embryo stages until the birth of the baby"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy pregnant women between the age of 18-35 at gestational age of 25-40 weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between the ages of 18-35\n* Gestational age between 25-40 weeks\n* Low risk pregnancies\n\nExclusion Criteria:\n\n* Multiple gestation\n* Fetal brain abnormality'}, 'identificationModule': {'nctId': 'NCT03168932', 'briefTitle': "Quantification of Fetal Brains' Sulci Along Gestation", 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': "Detecting and Quantifying Sulci and White Matter in Fetus' Brain Along the Third Stage of Gestation", 'orgStudyIdInfo': {'id': '0398-14-RMB'}}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yuval Ginsberg, MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}