Maternal & Infant Morbidity and Mortality

Infant, Premature, Diseases Clinical Trial

Official title:

Maternal & Infant Morbidity and Mortality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06145568
• Other study ID #: HSR230385
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2033

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: Emily Chuang, MA
• Phone: 4349824497
• Email: qgz2tk[@]uvahealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pregnant women

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Hemorrhage
• Hypertension
• Infant, Premature, Diseases
• Pregnancy Complications

Intervention

Other:
• Pregnant Women
We want to quantify Minority Americans at risk of pregnancy complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy complications as a function of minority status	Pregnancy complications as a function of minority status	10 years

External Links

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