Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT03579069
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2018-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ductus Venosus Doppler at 16 Weeks in Monochorial Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-07-05', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a twin to twin transfusion syndrome', 'timeFrame': '1 day', 'description': 'Occurrence of a twin to twin transfusion syndrome during pregnancy'}], 'secondaryOutcomes': [{'measure': 'neonatal mortality rate', 'timeFrame': '1 day', 'description': 'neonatal mortality rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ductus venosus Doppler'], 'conditions': ['Twin Pregnancy, Monochorionic', 'Pregnancy Followed']}, 'descriptionModule': {'briefSummary': "Studies shows that the realization of the Ductus venosus Doppler may improve the screening of the twin-twin transfusion syndrome. In this study, we want to compare the outcome of monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and when it wasn't. In order to do that, we will compile past reports (January 2015/ January 2018) of all monochorial pregnancy handled in the hospital of Montpellier and Kremlin Bicêtre. We will establish if the Doppler was done or not, if the twin-twin transfusion syndrome appears and the neonatal outcome."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Monochorionic diamniotic twin pregnancies\n* Monochorionicity diagnosed at the first-trimester\n* Follow up and ultrasound realized at the hospital of Montpellier or Kremlin Bicêtre\n* Screening for twin-twin transfusion syndrome achieved\n\nExclusion criteria:\n\n* Missing ultrasound\n* Unregistered outcome of the pregnancy\n* Eclampsia and pre-eclampsia'}, 'identificationModule': {'nctId': 'NCT03579069', 'acronym': 'DVSTT', 'briefTitle': 'Ductus Venosus Doppler at 16 Weeks in Monochorial Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Does the Performance of the Ductus Venosus Doppler at 16 Weeks Allow to Increase the Screening of the Twin-twin Transfusion Syndrome and to Reduce the Neonatal Mortality?', 'orgStudyIdInfo': {'id': 'RECHMPL18_0254'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ductus venosus Doppler realized', 'description': 'Ductus venosus Doppler realized', 'interventionNames': ['Other: Ductus venosus Doppler']}, {'label': 'Ductus venosus Doppler unrealized', 'description': 'Ductus venosus Doppler unrealized'}], 'interventions': [{'name': 'Ductus venosus Doppler', 'type': 'OTHER', 'description': 'Ductus venosus Doppler', 'armGroupLabels': ['Ductus venosus Doppler realized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Celine FOREL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}