Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-28 @ 2:43 PM
Study NCT ID:
NCT06145568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal & Infant Morbidity and Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy complications as a function of minority status', 'timeFrame': '10 years', 'description': 'Pregnancy complications as a function of minority status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy complications; hemorrhagic; hypertension; premature infants; bleeding'], 'conditions': ['Preg Complications: Hemorrhagic', 'Infant, Premature, Diseases', 'Preg Complications: Hemorrhagic Intervillous of Placenta', 'Preg Complications: Bleeding From Female Genital Tract', 'Preg Complic - Malig Hypertension and / or Reason for Care During Childbirth']}, 'referencesModule': {'references': [{'pmid': '36988993', 'type': 'BACKGROUND', 'citation': 'Harris E. US Maternal Mortality Continues to Worsen. JAMA. 2023 Apr 18;329(15):1248. doi: 10.1001/jama.2023.5254. No abstract available.'}, {'pmid': '33646291', 'type': 'BACKGROUND', 'citation': 'Himmelstein G, Desmond M. Association of Eviction With Adverse Birth Outcomes Among Women in Georgia, 2000 to 2016. JAMA Pediatr. 2021 May 1;175(5):494-500. doi: 10.1001/jamapediatrics.2020.6550.'}, {'pmid': '33197038', 'type': 'BACKGROUND', 'citation': 'Johnson-Agbakwu CE, Ali NS, Oxford CM, Wingo S, Manin E, Coonrod DV. Racism, COVID-19, and Health Inequity in the USA: a Call to Action. J Racial Ethn Health Disparities. 2022 Feb;9(1):52-58. doi: 10.1007/s40615-020-00928-y. Epub 2020 Nov 16.'}, {'pmid': '35337375', 'type': 'BACKGROUND', 'citation': 'Boyer BT, Lowell GS, Roehler DR, Quinlan KP. Racial and ethnic disparities of sudden unexpected infant death in large US cities: a descriptive epidemiological study. Inj Epidemiol. 2022 Mar 25;9(1):12. doi: 10.1186/s40621-022-00377-7.'}], 'seeAlsoLinks': [{'url': 'https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm#fig1', 'label': 'Maternal Mortality Rates in the United States, 2021 (cdc.gov)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children.\n\nThe EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty/staff.', 'detailedDescription': 'The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health. Our hypothesis is that patients with minority status, particularly Black and Hispanic Americans, are more likely to have poor outcomes (based on various health metrics) compared to Non-Black, Non-Hispanic patients. We hypothesize further that it is likely not far off from national trends, which indicate that Black parturients are x4 more likely to die during childbirth, and Black children are 2.4x more likely to die before their first birthday than Non-Hispanic White children.\n\nThe EPIC database will be used on an institutional basis to obtain information and accessed by UVA statistician to perform the research described in this submission. The dataset does contain a few direct identifiers of medical record numbers, dates, and postal number. We anticipate that all statistical analysis will be performed at UVA by participating faculty/staff.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06145568', 'briefTitle': 'Maternal & Infant Morbidity and Mortality', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Maternal & Infant Morbidity and Mortality', 'orgStudyIdInfo': {'id': 'HSR230385'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant Women', 'description': 'Pregnant Women', 'interventionNames': ['Other: Pregnant Women']}], 'interventions': [{'name': 'Pregnant Women', 'type': 'OTHER', 'description': 'We want to quantify Minority Americans at risk of pregnancy complications', 'armGroupLabels': ['Pregnant Women']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emily Chuang, MA', 'role': 'CONTACT', 'email': 'qgz2tk@uvahealth.org', 'phone': '4349824497'}, {'name': 'Keita Ikeda, PhD', 'role': 'CONTACT', 'email': 'ki2d@uvahealth.org', 'phone': '4349248621'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Ebony Hilton', 'investigatorFullName': 'Ebony Hilton', 'investigatorAffiliation': 'University of Virginia'}}}}