Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT00340002
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2006-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fetal Anatomy by Three-Dimensional Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-11-26'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2006-06-19', 'studyFirstSubmitQcDate': '2006-06-19', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fetal Anatomy', 'timeFrame': 'Ongoing', 'description': 'Data analysis is ongoing'}]}, 'conditionsModule': {'keywords': ['Fetal Anatomy', 'Pregnancy', 'Prenatal Diagnosis', 'Natural History'], 'conditions': ['Preterm Birth', 'Pregnancy', 'Fetal Growth Abnormalities']}, 'referencesModule': {'references': [{'pmid': '1550157', 'type': 'BACKGROUND', 'citation': 'Kuo HC, Chang FM, Wu CH, Yao BL, Liu CH. The primary application of three-dimensional ultrasonography in obstetrics. Am J Obstet Gynecol. 1992 Mar;166(3):880-6. doi: 10.1016/0002-9378(92)91355-e.'}, {'pmid': '8178859', 'type': 'BACKGROUND', 'citation': 'Lee A, Deutinger J, Bernaschek G. "Voluvision": three-dimensional ultrasonography of fetal malformations. Am J Obstet Gynecol. 1994 May;170(5 Pt 1):1312-4. doi: 10.1016/s0002-9378(94)70148-2.'}, {'pmid': '7836537', 'type': 'BACKGROUND', 'citation': 'Steiner H, Staudach A, Spitzer D, Schaffer H. Three-dimensional ultrasound in obstetrics and gynaecology: technique, possibilities and limitations. Hum Reprod. 1994 Sep;9(9):1773-8. doi: 10.1093/oxfordjournals.humrep.a138793.'}]}, 'descriptionModule': {'briefSummary': 'A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to scan through a digital ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and render anatomical features through computer processing. However, the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy.\n\nWe are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of up to 1,400 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages. The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography.\n\nAll cases will be placed into a digital image database. For each anomaly category, volume reconstructions will be compared to normal anatomy at specific gestational ages. Key diagnostic findings will be documented and correlated with postnatal outcome. We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy.', 'detailedDescription': 'A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to scan through a digital ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and render anatomical features through computer processing. However, the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy.\n\nWe are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of up to 7,000 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages. A subset of the fetuses enrolled in this protocol will also be examined by Magnetic Resonance Imaging (MRI) to identify potential advantages and limitations of this imaging modality when compared to 3DUS for the diagnosis of congenital anomalies. The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography.\n\nAll cases will be placed into a digital image database. For each anomaly category, volume data will be acquired at specific gestational ages. Key diagnostic features will be documented and correlated with postnatal outcome. Postnatal correlative studies may include ultrasound, MRI, X-ray, computerized tomography (CT), and photography. We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women attending Detroit Medical Center prenatal clinics in Detroit.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nAll pregnant subjects will be recruited under informed consent at either Hutzel or William Beaumont Hospitals.\n\nThe study population for both arms of this protocol will involve pregnant women greater than or equal to 15 years.\n\nCROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:\n\n3DUS STUDIES:\n\nNo fetal anomalies suspected by 2DUS.\n\nExcellent visualization of normal fetal anatomy by 2DUS.\n\nAccurate dating criteria by 1st trimester scan and/or menstrual history.\n\nFETAL MRI STUDIES:\n\nGestational age between 18-42 menstrual weeks.\n\nNo known fetal abnormalities.\n\nCROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:\n\n3DUS STUDIES:\n\nCongenital anomaly suspected by 2DUS.\n\nAccurate dating criteria by 1st trimester scan and/or menstrual history.\n\nFETAL MRI STUDIES:\n\nGestational age between 18-42 menstrual weeks.\n\nSuspected fetal abnormalities.\n\nPOSTMORTEM STUDIES:\n\nSuspected fetal abnormalities by prenatal ultrasound.\n\nEXCLUSION CRITERIA:\n\nCROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:\n\n3DUS STUDIES:\n\nPoor visualization of the fetus due to technical factors (e.g. obesity, surgical scar).\n\nHistory of noncompliance with prenatal visits with the current or prior pregnancy.\n\nFETAL MRI STUDIES:\n\nInability of the patient to fit in bore of MRI system.\n\nMetallic implants that would increase risk to patient.\n\nPrevious occupational exposure to metal shop.\n\nHistory of claustrophobia.\n\nCROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:\n\n3DUS STUDIES:\n\nPoor fetal visualization from technical factors (e.g. obesity or decreased amniotic fluid).\n\nFETAL MRI STUDIES:\n\nInability of the patient to fit in bore of MRI system.\n\nMetallic implants that would increase risk to patient.\n\nPrevious occupational exposure to metal shop.\n\nHistory of claustrophobia.\n\nPOSTMORTEM STUDIES:\n\nRefusal to sign informed consent for postmortem imaging studies.'}, 'identificationModule': {'nctId': 'NCT00340002', 'briefTitle': 'Fetal Anatomy by Three-Dimensional Ultrasound', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Fetal Anatomy by Three-Dimensional Ultrasound', 'orgStudyIdInfo': {'id': '999997065'}, 'secondaryIdInfos': [{'id': 'OH97-CH-N065'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women', 'description': 'Pregnant women aged 18 years and older'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Hutzel Women's Hospital", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Roberto Romero, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}