NCT06145568

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Dec 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Dec 2023Dec 2033

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

10.1 years

First QC Date

November 17, 2023

Last Update Submit

November 17, 2023

Conditions

Preg Complications: HemorrhagicInfant, Premature, DiseasesPreg Complications: Hemorrhagic Intervillous of PlacentaPreg Complications: Bleeding From Female Genital TractPreg Complic - Malig Hypertension and / or Reason for Care During Childbirth

Keywords

pregnancy complications; hemorrhagic; hypertension; premature infants; bleeding

Outcome Measures

Primary Outcomes (1)

  • Pregnancy complications as a function of minority status

    Pregnancy complications as a function of minority status

    10 years

Study Arms (1)

Pregnant Women

Pregnant Women

Other: Pregnant Women

Interventions

Pregnant WomenOTHER

We want to quantify Minority Americans at risk of pregnancy complications

Pregnant Women

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

  • pregnant women

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 36988993BACKGROUND

  • 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: 33646291BACKGROUND

  • 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: 33197038BACKGROUND

  • 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.

    PMID: 35337375BACKGROUND

Related Links

MeSH Terms

Conditions

Infant, Premature, DiseasesPregnancy ComplicationsHypertensionPremature BirthHemorrhage

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Emily Chuang, MA

CONTACT

4349824497qgz2tk@uvahealth.org

Keita Ikeda, PhD

CONTACT

4349248621ki2d@uvahealth.org

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ebony Hilton

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share