Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04508751
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2020-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PED NEONAT 20-000599 Fetal Body Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kcalkins@mednet.ucla.edu', 'phone': '3108259330', 'title': 'Dr. Kara Calkins', 'organization': 'University of California Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Because this is a pilot study, our sample size is limited, and the results should be considered exploratory. We did not longitudinally measure body composition during pregnancy and infancy. Future follow-up would be required to understand if maternal and fetal body composition are truly associated with future childhood and adulthood obesity and various metabolic complications.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Pregnancy', 'description': 'Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'GDM was defined as a positive glucola screen at 26 to 32 weeks gestation.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'IUGR was defined as fetal weight and abdominal circumference \\<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maternal Visceral Adipose Tissue Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Pregnancy', 'description': 'Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM.'}, {'id': 'OG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'GDM was defined as a positive glucola screen at 26 to 32 weeks gestation.'}, {'id': 'OG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'IUGR was defined as fetal weight and abdominal circumference \\<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes'}], 'classes': [{'categories': [{'measurements': [{'value': '97593', 'groupId': 'OG000', 'lowerLimit': '78014', 'upperLimit': '121081'}, {'value': '169626', 'groupId': 'OG001', 'lowerLimit': '137736', 'upperLimit': '227035'}, {'value': '96787', 'groupId': 'OG002', 'lowerLimit': '82327', 'upperLimit': '184784'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Visceral adipose tissue PDFF values will be directly measured from regions of interest.', 'unitOfMeasure': 'mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fetal Liver PDFF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Pregnancy', 'description': 'Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM.'}, {'id': 'OG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'GDM was defined as a positive glucola screen at 26 to 32 weeks gestation.'}, {'id': 'OG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'IUGR was defined as fetal weight and abdominal circumference \\<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '3.3'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.5'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images. The distribution/extent of hepatic fat will be manually delineated/drawn on the 3D MRI images and PDFF maps. This work will be performed by PI Strobel with validation from PI Wu.', 'unitOfMeasure': 'percentage of triglycerides/', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fetal Subcutaneous Tissue Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Pregnancy', 'description': 'Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM.'}, {'id': 'OG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'GDM was defined as a positive glucola screen at 26 to 32 weeks gestation.'}, {'id': 'OG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'IUGR was defined as fetal weight and abdominal circumference \\<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000', 'lowerLimit': '232', 'upperLimit': '255'}, {'value': '280', 'groupId': 'OG001', 'lowerLimit': '261', 'upperLimit': '295'}, {'value': '220', 'groupId': 'OG002', 'lowerLimit': '205', 'upperLimit': '235'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Subcutaneous adipose tissue PDFF values will be directly measured from regions of interest.', 'unitOfMeasure': 'mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Subcutaneous Tissue Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Pregnancy', 'description': 'Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM.'}, {'id': 'OG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'GDM was defined as a positive glucola screen at 26 to 32 weeks gestation.'}, {'id': 'OG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'IUGR was defined as fetal weight and abdominal circumference \\<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes'}], 'classes': [{'categories': [{'measurements': [{'value': '157319', 'groupId': 'OG000', 'lowerLimit': '126300', 'upperLimit': '200028'}, {'value': '216264', 'groupId': 'OG001', 'lowerLimit': '161461', 'upperLimit': '325975'}, {'value': '159197', 'groupId': 'OG002', 'lowerLimit': '84024', 'upperLimit': '339707'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images. The distribution/extent of subcutaneous fat will be manually delineated/drawn on the 3D MRI images and PDFF maps and used to calculate volume of subcutaneous adipose tissue. This work will be performed by PI Strobel with validation from PI Wu.', 'unitOfMeasure': 'mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Hepatic Fat PDFF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Pregnancy', 'description': 'Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM.'}, {'id': 'OG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'GDM was defined as a positive glucola screen at 26 to 32 weeks gestation.'}, {'id': 'OG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'IUGR was defined as fetal weight and abdominal circumference \\<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.8'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.8'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Hepatic adipose tissue PDFF values will be directly measured from regions of interest.', 'unitOfMeasure': '% triglycerides', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Pregnancy', 'description': 'Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines.\n\nMaternal demographics, pregnancy clinical course and infant growth parameters will be recorded.\n\n3T "Free-Breathing" Fetal Magnetic Resonance Imaging: Subject will have a one time MRI scan.'}, {'id': 'FG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines.\n\nMaternal demographics, pregnancy clinical course and infant growth parameters will be recorded.\n\n3T "Free-Breathing" Fetal Magnetic Resonance Imaging: Subject will have a one time MRI scan.'}, {'id': 'FG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines.\n\nMaternal demographics, pregnancy clinical course and infant growth parameters will be recorded.\n\n3T "Free-Breathing" Fetal Magnetic Resonance Imaging: Subject will have a one time MRI scan.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Discontinued study early due to maternal discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruited by study investigator or obstetrician through medical clinic.', 'preAssignmentDetails': 'One subject was excluded due to inability to schedule MRI scan'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Pregnancy', 'description': 'Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM.'}, {'id': 'BG001', 'title': 'Pregnant Mothers With Gestational Diabetes', 'description': 'GDM was defined as a positive glucola screen at 26 to 32 weeks gestation.'}, {'id': 'BG002', 'title': 'Pregnant Mothers With Infants Diagnosed With IUGR', 'description': 'IUGR was defined as fetal weight and abdominal circumference \\<10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'BG000', 'lowerLimit': '29.8', 'upperLimit': '38'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '30.5', 'upperLimit': '36.5'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '27.5', 'upperLimit': '36'}, {'value': '34.5', 'groupId': 'BG003', 'lowerLimit': '29.25', 'upperLimit': '36.75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Glucose tolerance test at 1 hour', 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000', 'lowerLimit': '62', 'upperLimit': '112'}, {'value': '182', 'groupId': 'BG001', 'lowerLimit': '157', 'upperLimit': '191'}, {'value': '131', 'groupId': 'BG002', 'lowerLimit': '102', 'upperLimit': '146'}, {'value': '109', 'groupId': 'BG003', 'lowerLimit': '73', 'upperLimit': '151'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-20', 'size': 563758, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-03T23:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Pregnant mothers who's infants were diagnosed with intrauterine growth restriction and mothers with pregnancies complicated by gestational diabetes, and mothers with healthy uncomplicated pregnancies will be recruited to have a fetal MRI in the third trimester."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2020-08-03', 'resultsFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-19', 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Visceral Adipose Tissue Volume', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Visceral adipose tissue PDFF values will be directly measured from regions of interest.'}, {'measure': 'Fetal Liver PDFF', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images. The distribution/extent of hepatic fat will be manually delineated/drawn on the 3D MRI images and PDFF maps. This work will be performed by PI Strobel with validation from PI Wu.'}], 'secondaryOutcomes': [{'measure': 'Fetal Subcutaneous Tissue Volume', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Subcutaneous adipose tissue PDFF values will be directly measured from regions of interest.'}, {'measure': 'Maternal Subcutaneous Tissue Volume', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images. The distribution/extent of subcutaneous fat will be manually delineated/drawn on the 3D MRI images and PDFF maps and used to calculate volume of subcutaneous adipose tissue. This work will be performed by PI Strobel with validation from PI Wu.'}, {'measure': 'Maternal Hepatic Fat PDFF', 'timeFrame': 'During the procedure (MRI)', 'description': 'MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps. The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis. Hepatic adipose tissue PDFF values will be directly measured from regions of interest.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IUGR', 'Gestational Diabetes', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Obesity is an ongoing public health problem that is difficult to treat. There is evidence that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown, and hepatic fat have been found to be important predictors in obesity and metabolic syndrome. Magnetic resonance imaging (MRI) can quantify body composition that does not require radiation but is motion limited. The investigators have developed a motion-compensated MRI sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with gestational diabetes. The different types of adipose tissue will be measured and compared between groups and correlated to birth growth parameters. The goal is this study is to assess if motion-compensated MRI can help predict early growth patterns in infancy.', 'detailedDescription': "1.1 OBJECTIVE This study's goals are to: 1) use free-breathing magnetic resonance imaging (FB-MRI) to measure fetal body composition in the third trimester and 2) determine how the FB-MRI quantitative measurements compare to growth parameters at birth.\n\n1.2 HYPOTHESES AND SPECIFIC AIMS\n\nTo accomplish the investigators' objectives, the aims and hypotheses are as follows:\n\nSpecific Aim 1:\n\nIn a prospective study in women with healthy pregnancies and women with fetuses that have intrauterine growth restriction (IUGR) and gestational diabetes, the investigators will quantify fetal subcutaneous, visceral, and brown adipose tissue volumes and proton-density fat fraction (PDFF) using FB-MRI in the third trimester.\n\nHypothesis 1: Using a FB-MRI technique the investigators will find the following,\n\n1. The growth-restricted fetus will have less visceral, subcutaneous, and brown adipose tissue volume and PDFF when compared to healthy fetuses and fetuses whose mothers have gestational diabetes.\n2. Fetuses whose mothers have gestational diabetes will have a greater subcutaneous and visceral adipose tissue volume and PDFF compared to healthy fetuses.\n\nSpecific Aim 2:\n\nIn a prospective study in pregnant women and their fetuses, the investigators will compare volume and PDFF measurements of fetal visceral, subcutaneous, and brown adipose tissue obtained with FB-MRI to birth growth parameters of these infants.\n\nHypothesis 2: The volume and PDFF of fetal visceral and subcutaneous adipose tissue will correlate positively with birth weight and length z-score."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identified female patients who are pregnant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with singleton pregnancies (healthy cohort)\n* Pregnant women with fetuses with weights \\< 10th percentile weight for gestational age (IUGR cohort)\n* Pregnant women with gestational diabetes (diabetes cohort)\n\nExclusion Criteria:\n\n* Pregnant minors\n* Major congenital anomalies or disease processes in the fetus\n* Fetus with known chromosomal anomalies\n* Mothers who do not plan to deliver at UCLA\n* Multiple pregnancy (i.e. twins, triplets, etc)\n* History of claustrophobia\n* Contraindications to MRI such as metallic devices in the body that are not MRI compatible'}, 'identificationModule': {'nctId': 'NCT04508751', 'briefTitle': 'PED NEONAT 20-000599 Fetal Body Composition', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Fetal Body Composition and Free-Breathing Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': '20-000599'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Pregnancy', 'description': 'Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines.\n\nMaternal demographics, pregnancy clinical course and infant growth parameters will be recorded.', 'interventionNames': ['Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging']}, {'type': 'OTHER', 'label': 'Pregnant Mothers with gestational diabetes', 'description': 'Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines.\n\nMaternal demographics, pregnancy clinical course and infant growth parameters will be recorded.', 'interventionNames': ['Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging']}, {'type': 'OTHER', 'label': 'Pregnant Mothers with infants diagnosed with IUGR', 'description': 'Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines.\n\nMaternal demographics, pregnancy clinical course and infant growth parameters will be recorded.', 'interventionNames': ['Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging']}], 'interventions': [{'name': '3T "Free-Breathing" Fetal Magnetic Resonance Imaging', 'type': 'OTHER', 'description': 'Subject will have a one time MRI scan.', 'armGroupLabels': ['Healthy Pregnancy', 'Pregnant Mothers with gestational diabetes', 'Pregnant Mothers with infants diagnosed with IUGR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'University of California- Los Angeles Santa Monica', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Katie Strobel, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}