Viewing Study NCT06145568



Ignite Creation Date: 2024-05-06 @ 7:49 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06145568
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-11-24
First Post: 2023-11-17

Brief Title: Maternal Infant Morbidity and Mortality
Sponsor: University of Virginia
Organization: University of Virginia

Study Overview

Official Title: Maternal Infant Morbidity and Mortality
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 24x 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 facultystaff
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 24x 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 facultystaff

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None