Maternal & Infant Morbidity and Mortality | NCT06145568

Studies
Maternal & Infant Morbidity and Mortality

NCT06145568

Sponsor

University of Virginia

Status

Not yet recruiting

Last Update Posted

Nov 24, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

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

Interventions

Pregnant Women

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 31, 2033Estimated

Completion Date

Dec 31, 2033Estimated

First Submitted Date

Nov 17, 2023

First Submission Date that Met QC Criteria

Nov 17, 2023

First Posted Date

Nov 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2023

Last Update Posted Date

Nov 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ebony Hilton, Dr. Ebony Hilton, University of VirginiaPrincipal Investigator

Lead Sponsor

University of VirginiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Conditions Module

Conditions

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

Keywords

pregnancy complications; hemorrhagic; hypertension; premature infants; bleeding

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant Women		Pregnant Women	Other: Pregnant Women

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregnant Women	Other	We want to quantify Minority Americans at risk of pregnancy complications	Pregnant Women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy complications as a function of minority status	Pregnancy complications as a function of minority status	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emily Chuang, MA	Contact	4349824497		qgz2tk@uvahealth.org
Keita Ikeda, PhD	Contact	4349248621		ki2d@uvahealth.org

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36988993	Background	Harris E. US Maternal Mortality Continues to Worsen. JAMA. 2023 Apr 18;329(15):1248. doi: 10.1001/jama.2023.5254. No abstract available.
33646291	Background	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.

ID	Term
D007235	Infant, Premature, Diseases
D011248	Pregnancy Complications
D006973	Hypertension
D047928	Premature Birth
D006470	Hemorrhage

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms