Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-28 @ 12:34 AM
Study NCT ID:
NCT06178250
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '46 pregnant women diagnosed with gestational diabetes mellitus, 93 pregnant women with normal glycemic index'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-12-03', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Placenta volume in ultrasound', 'timeFrame': '10 months', 'description': 'Measured placenta volumes of pregnant women with GDM diagnosis and normal glycemic indices and evaluate their success in predicting poor obstetrics outcomes'}, {'measure': 'Fetal liver volume in ultrasound', 'timeFrame': '10 months', 'description': 'Measured fetal liver and ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices and evaluate their success in predicting poor obstetrics outcomes'}, {'measure': 'Ductus venosus volume in ultrasound', 'timeFrame': '10 months', 'description': 'Measured ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices and evaluate their success in predicting poor obstetrics outcomes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GESTATİONAL DİABETES MELLİTUS', 'PLACENTA VOLUME', 'FETAL LİVER VOLUME', 'DUCTUS VENOSUS VOLUME', '3D SONUGRAPHY'], 'conditions': ['Gestational Diabetes', 'DUCTUS VENOSUS VOLUME', 'PLACENTA VOLUME', '3D SONOGRAPHY', 'FETAL LİVER VOLUME']}, 'descriptionModule': {'briefSummary': 'Investigators measured the placenta, fetal liver and ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices in the second trimester.Investigators aimed to correlate measurements with maternal/fetal outcomes and evaluate their success in predicting poor obstetric outcomes', 'detailedDescription': 'GDM screening may not always be possible with OGTT performed in limited weeks of gestation. In addition, mid-trimester ultrasound scanning is done in all pregnancies. Therefore, measurement of placental volume and fetal liver volume may be an alternative method for the diagnosis of GDM. In order to predict GDM in the second trimester, the use of 3D sonography and VOCAL (Virtual Organ Computer Aided Analysis) technology in high-risk pregnant women and their cost-effectiveness rates should be investigated further. Multicenter randomized controlled studies with more patients are needed to be able to say more clearly.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancy\n* diagnosed with GDM\n\nExclusion Criteria:\n\n* multiple pregnancy\n* congenital anomalies\n* gestational hypertansion\n* preeclampsia'}, 'identificationModule': {'nctId': 'NCT06178250', 'briefTitle': 'Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester', 'organization': {'class': 'OTHER', 'fullName': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}, 'officialTitle': 'The Role of Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester in Predicting Gestational Diabetes Mellitus and Maternal-fetal Outcomes', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2021/10-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'placenta, fetal liver, sectional ductus venosus volumes between 24-29 weeks pregnant women', 'description': 'The placenta, fetal liver and ductus venosus volumes of 46 patients diagnosed with GDM and 93 patients without a GDM diagnosis between 24-29 weeks were evaluated with 3D ultrasound.', 'interventionNames': ['Other: 3D sonography']}], 'interventions': [{'name': '3D sonography', 'type': 'OTHER', 'otherNames': ['3D volume description'], 'description': 'Fetal liver, placenta, and ductus venosus were defined in 3 orthogonal multi-plane images in the voluson 4D view vocal program.', 'armGroupLabels': ['placenta, fetal liver, sectional ductus venosus volumes between 24-29 weeks pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Nefise Nazlı YENIGUL', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D. Assistant Professor Department of Obstetrics and Gynecology', 'investigatorFullName': 'Nefise Nazlı YENIGUL', 'investigatorAffiliation': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}}}}