Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-12 @ 7:09 AM
Study NCT ID:
NCT03861520
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2019-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Fetal Soft Markers and Aneuploidy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fetal karyotyping'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-05', 'studyFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the association between soft markers identified at second trimester ultrasound and aneuploidy.', 'timeFrame': '1 year', 'description': 'fetal soft markers detection which include the following:\n\n* choroid plexus cyst.\n* Mild ventriculomegaly.\n* Enlarged cistern magna.\n* Nasal bone hypoplasia.\n* Increased nuchal fold.\n* Echogenic cardiac focus.\n* Single umbilical artery.\n* Pyelectasis.\n* Echogenic bowl.\n* Short femur.\n* Short humerus.\n\nAll data will be collected and statistics will be done for the correlation between one or more soft markers with structural anomalies and its relation with aneuploidy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anomaly scan', 'Anuploidy'], 'conditions': ['Soft Markers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the prevalence of soft markers which will be identified during a second trimester ultrasound. Secondary aims were to estimate the association between the soft markers and trisomies 13, 18 and 21 as well as the effect on the number of invasive tests will be performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pregnant woman between (16-24) weeks of gestation.\n2. singelton pregnancy.\n\nExclusion Criteria:\n\n1. Multiple pregnancies.\n2. Mental condition rendering the patients unable to understand the nature and scope of the study.'}, 'identificationModule': {'nctId': 'NCT03861520', 'briefTitle': 'Ultrasonographic Fetal Soft Markers and Aneuploidy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between Ultrasonographic Fetal Soft Markers and Aneuploidy', 'orgStudyIdInfo': {'id': '12019'}}, 'armsInterventionsModule': {'armGroups': [{'label': '16-24 weeks Pregnant womes', 'description': 'Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more.', 'interventionNames': ['Device: Midtrimester anomaly scan', 'Genetic: Fetal Karyotyping']}], 'interventions': [{'name': 'Midtrimester anomaly scan', 'type': 'DEVICE', 'otherNames': ['2nd trimester anomaly scan'], 'description': 'A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy', 'armGroupLabels': ['16-24 weeks Pregnant womes']}, {'name': 'Fetal Karyotyping', 'type': 'GENETIC', 'description': 'Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically', 'armGroupLabels': ['16-24 weeks Pregnant womes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Maha M Mossad, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yasmin Ahmed Bassiouny', 'investigatorAffiliation': 'Cairo University'}}}}