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Maternal & Infant Morbidity and Mortality

NCT ID: NCT06145568

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2033-12-31

Brief Summary

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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.

The 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.

Detailed Description

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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.

The 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.

Conditions

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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

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pregnant Women

Pregnant Women

Pregnant Women

Intervention Type OTHER

We want to quantify Minority Americans at risk of pregnancy complications

Interventions

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Pregnant Women

We want to quantify Minority Americans at risk of pregnancy complications

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pregnant women

Exclusion Criteria

* N/A
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Ebony Hilton

Dr. Ebony Hilton

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Emily Chuang, MA

Role: CONTACT

[email protected]
4349824497

Keita Ikeda, PhD

Role: CONTACT

[email protected]
4349248621

References

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Harris E. US Maternal Mortality Continues to Worsen. JAMA. 2023 Apr 18;329(15):1248. doi: 10.1001/jama.2023.5254. No abstract available.

Reference Type BACKGROUND
PMID: 36988993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33646291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33197038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35337375 (View on PubMed)

Related Links

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https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm#fig1

Maternal Mortality Rates in the United States, 2021 (cdc.gov)

Other Identifiers

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HSR230385

Identifier Type: -

Identifier Source: org_study_id