Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-01 @ 9:58 PM
Study NCT ID:
NCT03697902
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2018-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Imaging Angle in Measurement of Cisterna Magna
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-28', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cisterna Magna length', 'timeFrame': '24 hours', 'description': 'The length measurement on the CM with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Measurements of the anteroposterior diameter Will be obtained along straight lines between the posterior border of the cerebellar vermis and the internal face of the occipital bone.'}], 'secondaryOutcomes': [{'measure': 'Cisterna Magna length according to fetal presentation', 'timeFrame': '24 hours', 'description': 'The length measurement on the CM with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Measurements will be made in fetuses with cephalic and breech presentation. Another measurement will be made in fetuses with cephalic presentation that had converted to breech presentation or viceversa in less than 24 hours.'}, {'measure': 'Cisterna Magna length according to fetal sex', 'timeFrame': '24 hours', 'description': 'The length measurement on the cisterna magna (CM) with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput. Those measurements will be compare between male and female fetuses.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cisterna magna length', 'ultrasound'], 'conditions': ['Fetal Cisterna Magna Length', 'Ultrasonography']}, 'referencesModule': {'references': [{'pmid': '15736211', 'type': 'BACKGROUND', 'citation': 'Cho JY, Kim KW, Lee YH, Toi A. Measurement of nuchal skin fold thickness in the second trimester: influence of imaging angle and fetal presentation. Ultrasound Obstet Gynecol. 2005 Mar;25(3):253-7. doi: 10.1002/uog.1847.'}, {'pmid': '24122018', 'type': 'BACKGROUND', 'citation': 'Araujo Junior E, Martins WP, Rolo LC, Pires CR, Zanforlin Filho SM. Normative data for fetal cisterna magna length measurement between 18 and 24 weeks of pregnancy. Childs Nerv Syst. 2014 Jan;30(1):9-12. doi: 10.1007/s00381-013-2298-y.'}, {'pmid': '12692827', 'type': 'BACKGROUND', 'citation': 'Serhatlioglu S, Kocakoc E, Kiris A, Sapmaz E, Boztosun Y, Bozgeyik Z. Sonographic measurement of the fetal cerebellum, cisterna magna, and cavum septum pellucidum in normal fetuses in the second and third trimesters of pregnancy. J Clin Ultrasound. 2003 May;31(4):194-200. doi: 10.1002/jcu.10163.'}, {'pmid': '28370151', 'type': 'BACKGROUND', 'citation': 'Liu Z, Han J, Fu F, Liu J, Li R, Yang X, Pan M, Zhen L, Li D, Liao C. Outcome of isolated enlarged cisterna magna identified in utero: experience at a single medical center in mainland China. Prenat Diagn. 2017 Jun;37(6):575-582. doi: 10.1002/pd.5046. Epub 2017 May 10.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to determine the effect of imaging angle on the measurement of fetal cisterna magna (CM) in the second trimester.\n\nFetal CM will be prospectively measured in women at 18-24.6 weeks' gestation. Measurements will be made on different angles between the transducer and fetal cerebellar axial plane with internal landmarks.\n\nDesign: Observative, cross sectional", 'detailedDescription': 'Patients and methods: women with low risk single pregnancy will be studied. Fetuses with multiple pregnancies, maternal chronic disease and severe congenital anomalies except mega cisterna magna (MCM) will be excluded from the study. Measurements will be performed on the axial cerebellar plane.The anteroposterior measurement will be made between the posterior border of the cerebellar vermis and the internal face of the occipital bone.\n\nThe primary outcome variables will be cisterna magna length measured on different angles between the transducer and the axial cerebellar plane of the fetal head.\n\nCisterna magna length measurement related to fetal presentation and gender will be secondary outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with low risk pregnancy between the 18th and 24th weeks with confirm gestational age who wil be referred to our prenatal diagnosis unit for ultrasonography to be performed in their second trimester.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between the 18th and 24th weeks.\n* Confirmed gestational age by regular menstrual cycle or determined from crown- rump length at first trimester ultrasonography for those with unknown menstruation date .\n\nExclusion Criteria:\n\n* Uncertain gestational age\n* Twin or multiple pregnancy.\n* Increased risk for aneuploidy determined by first trimester screening.\n* Absence of intracranial translucency in first trimester ultrasound examination.\n* Fetal malformations identified EXCEPT megacisterna magna.\n* Karyotype anomaly.\n* Chronic maternal diseases such as arterial hypertension, diabetes mellitus, hypothyroidism and hyperthyroidism.\n* Failure to obtain accurate measurement for technical reasons.'}, 'identificationModule': {'nctId': 'NCT03697902', 'briefTitle': 'Influence of Imaging Angle in Measurement of Cisterna Magna', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Influence of Imaging Angle in Measurement of Cisterna Magna in the Second Trimester', 'orgStudyIdInfo': {'id': 'GI19-00010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasonographic Measurement on Fetal cisterna magna length', 'type': 'DIAGNOSTIC_TEST', 'description': 'The length measurement on the fetal cisterna magna (CM) with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput.\n\nMeasurements will be performed on the axial cerebellar plane using internal landmarks including the cavum septi pellucidi, thalamus, third ventricle, cerebral peduncles and cerebellar hemispheres.The anteroposterior measurement will be made between the posterior border of the cerebellar vermis and the internal face of the occipital bone.\n\nAll the ultrasonography examinations were performed abdominally, using 3-5 megahertz (MHz) transducers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario Dr. José Eleuterio González', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Flavio Hernández-Castro, Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Dr. José Eleuterio González UANL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator MD PhD Flavio Hernández Castro', 'investigatorFullName': 'Dr. med Flavio Hernández Castro', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}