Maternal & Infant Morbidity and Mortality

Sponsor
University of Virginia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06145568
Collaborator
(none)
1,000
121

Study Details

Study Description

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.

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Ecologic or Community
Time Perspective:
Retrospective
Official Title:
Maternal & Infant Morbidity and Mortality
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2033
Anticipated Study Completion Date :
Dec 31, 2033

Arms and Interventions

Arm Intervention/Treatment
Pregnant Women

Pregnant Women

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

Outcome Measures

Primary Outcome Measures

  1. Pregnancy complications as a function of minority status [10 years]

    Pregnancy complications as a function of minority status

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • pregnant women
Exclusion Criteria:
  • N/A

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ebony Hilton, Dr. Ebony Hilton, University of Virginia
ClinicalTrials.gov Identifier:
NCT06145568
Other Study ID Numbers:
  • HSR230385
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ebony Hilton, Dr. Ebony Hilton, University of Virginia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023