PainNCT04633824
Health Disparities on the Labor Floor
An observational study of Pain and Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Pregnancy Related
- What is being tested?
- Retrospective Electronic Medical Record Review
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Pregnancy
- Age >/= age 18 years
Who cannot join
- Women less than age 18 will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
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.
- Conditions
- Pain, Pregnancy Related
- Being tested
- Retrospective Electronic Medical Record Review
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Electronic Medical Record ReviewOther
Patients will be assessed retrospectively for evidence of successful or failed epidural extension in the setting of need for cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Patients with private insurance | Not described Receives: Other: Retrospective Electronic Medical Record Review | |
| Patients with public/self-payer insurance | Not described Receives: Other: Retrospective Electronic Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful extension of labor epidural catheter for cesarean section
labor epidural activation in the setting of cesarean section
Measured: from the time of admission to the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Feb 2021
- Primary completion1 Apr 2026
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick T Hussey, University of Alabama at Birmingham
- Investigators
- Patrick Hussey, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633824
- Sponsor's protocol ID
- IRB-300006294
- Other IDs
- UAB
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Disparities on the Labor Floor
- ClinicalTrials.gov ID
- NCT04633824
- Acronym / sponsor ID
- IRB-300006294
- Conditions
- Pain, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with private insurance | – | Other: Retrospective Electronic Medical Record Review |
| Patients with public/self-payer insurance | – | Other: Retrospective Electronic Medical Record Review |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Pregnancy
- Age >/= age 18 years
Key exclusion criteria (1 listed)
- Women less than age 18 will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Electronic Medical Record ReviewPatients will be assessed retrospectively for evidence of successful or failed epidural extension in the setting of need for cesarean section | Other | Patients with private insurance, Patients with public/self-payer insurance |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Hussey, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful extension of labor epidural catheter for cesarean section (time frame: from the time of admission to the time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.