Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:38 PM
Study NCT ID:
NCT05295667
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doppler and AFV for Outcome Prediction ın FGR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR)', 'timeFrame': '1 year', 'description': 'enterence to neonatal intensive care unit and severe fetal acidemia ( pH: \\>7.10)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Growth Retardation']}, 'referencesModule': {'references': [{'pmid': '32722822', 'type': 'BACKGROUND', 'citation': 'Stumpfe FM, Faschingbauer F, Kehl S, Pretscher J, Emons J, Gass P, Mayr A, Schmid M, Beckmann MW, Stelzl P. Amniotic-Umbilical-to-Cerebral Ratio - A Novel Ratio Combining Doppler Parameters and Amniotic Fluid Volume to Predict Adverse Perinatal Outcome in SGA Fetuses At Term. Ultraschall Med. 2022 Apr;43(2):159-167. doi: 10.1055/a-1205-0161. Epub 2020 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigator contrived a prospective study of AUCR to compare its association to adverse perinatal outcomes with other established doppler parameters, such as CPR and UCR within a population of suspected FGR fetuses at term.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A pregnant womens between 18-40 years of age with singleton pregnancy after 37 weeks of gestational age with FGR', 'genderDescription': 'Pregnant women with fetal growth retardation (FGR)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SİNGLETON PREGNANCİES WİTH FGR FETUSES\n* AFTER 37th GESTATİONAL WEEKS\n\nExclusion Criteria:\n\n* SİNGLE OR MUTİPL FETAL ANOMALİES\n* EVİDENCE OF İNTRAUTERİNE ENFECTİON'}, 'identificationModule': {'nctId': 'NCT05295667', 'briefTitle': 'Doppler and AFV for Outcome Prediction ın FGR', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Bakirkoy Maternity and Children Diseases Hospital'}, 'officialTitle': 'Combination of Doppler Measurements With Amniotic Fluid Volume for the Predicition of Perinatal Outcome in FGR', 'orgStudyIdInfo': {'id': 'Besimoglu01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fetal Growth Retardation Group', 'interventionNames': ['Diagnostic Test: Doppler measurement in combination with amniotic fluid volume']}], 'interventions': [{'name': 'Doppler measurement in combination with amniotic fluid volume', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasonographic evaluation', 'armGroupLabels': ['Fetal Growth Retardation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06810', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Bakirkoy Maternity and Children Diseases Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Proffesor', 'investigatorFullName': 'Osman Aşıcıoğlu', 'investigatorAffiliation': 'Istanbul Bakirkoy Maternity and Children Diseases Hospital'}}}}