- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633824
Health Disparities on the Labor Floor
April 6, 2026 updated by: Patrick T Hussey, University of Alabama at Birmingham
The Agency for Healthcare Research and Quality (AHRQ) defines a disparity as a difference or a gap that exist between two groups, which is both statistically significant, larger than 10%, and indicates poor quality for the minority (non-referent) group.
Despite advances in public health initiatives and medicine, disparities in healthcare are persistent.
For example, in the United States, maternal mortality ratio has doubled since 1987 to 2009 where African American women were 4 times as likely to die from childbirth.
Although there was no observed racial disparity in maternal deaths at University of Alabama Birmingham, there is anecdotal experience that may suggest health disparities do exist on the labor floor when examining neuraxial utilization and effectiveness.
This retrospective study will seek to examine the successful extension of labor analgesia for cesarean section as it relates to insurance status.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
2500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35249
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All women admitted to the labor and delivery unit from 1/1/2015 to 12/31/2019, who meet the above defined inclusion and exclusion criteria
Description
Inclusion Criteria:
- Pregnancy
- Age >/= age 18 years
Exclusion Criteria:
- Women less than age 18 will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with private insurance
|
Patients will be assessed retrospectively for evidence of successful or failed epidural extension in the setting of need for cesarean section
|
|
Patients with public/self-payer insurance
|
Patients will be assessed retrospectively for evidence of successful or failed epidural extension in the setting of need for cesarean section
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Successful extension of labor epidural catheter for cesarean section
Time Frame: from the time of admission to the time of delivery
|
labor epidural activation in the setting of cesarean section
|
from the time of admission to the time of delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Patrick Hussey, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Actual)
April 1, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
November 11, 2020
First Submitted That Met QC Criteria
November 11, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 6, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300006294
- UAB (Other Identifier: UAB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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