Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-01 @ 3:21 PM
Study NCT ID:
NCT03303768
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Diagnosis of Coarctations of the Aorta.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001017', 'term': 'Aortic Coarctation'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-13', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-05', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Search for ultrasound risk factors associated with diagnosis coarctation of the aorta', 'timeFrame': '24h after birth', 'description': 'Calculation of sensitivity, specificity and ROC (Receiver Operating Characteristic) curves of the different ultrasound parameters according to post-natal confirma-diagnosis of coarctation of the aorta in order to create a score to improve the antenatal diagnosis of coarctation the aorta.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coarctation of Aorta']}, 'descriptionModule': {'briefSummary': 'Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try to establish the diagnosis since it has been shown that the prenatal diagnosis improves survival and reduces morbidity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant or having given birth in the last 12 months in one of the participating centers\n* have had an ultrasound screening in the 2nd or 3rd trimester\n* addressed or being addressed to the Pluridisciplinary Center for Prenatal Diagnosis for suspected coarctation of isolated aorta in front of: ventricular asymmetry at the aegis of the left ventricle or the large vessels at the aorta, discovered during a screening ultrasound second or third quarter.\n* be able to understand and follow the ins and outs of the study\n* Have been informed of the study and have not objected to it\n\nExclusion Criteria:\n\n* Associated complex cardiac disease (transposition of large vessels, atrioventricular duct, right ventricle with double outlet) with the exception of inter ventricular communications\n* Left ventricular hypoplasia\n* Suspicion of interruption of the aortic arch'}, 'identificationModule': {'nctId': 'NCT03303768', 'acronym': 'CoA', 'briefTitle': 'Antenatal Diagnosis of Coarctations of the Aorta.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.', 'orgStudyIdInfo': {'id': '69HCL17_0477'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Pregnant woman with suspected coarctation of isolated aorta or woman followed in the last 12 for suspected coarctation of the aorta isolated during pregnancy', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Investigation of relevant ultrasound signs to improve the antenatal diagnosis of coarctation of the aorta by calculating the sensitivity and specificity of these different signs', 'armGroupLabels': ['Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}