Preg Complications: HemorrhagicNCT06145568
Maternal & Infant Morbidity and Mortality
An observational study of Preg Complications: Hemorrhagic and Infant, Premature, Diseases, run by University of Virginia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preg Complications: Hemorrhagic, Infant, Premature, Diseases, Preg Complications: Hemorrhagic Intervillous of Placenta
- What is being tested?
- Pregnant Women
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2033
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant women
Who may be able to join
- pregnant women
Who cannot join
- N/A
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- 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
- Being tested
- Pregnant Women
- Keywords
- pregnancy complications; hemorrhagic; hypertension; premature infants; bleeding
- Medical subject headings
- Infant, Premature, Diseases, Pregnancy Complications, Hypertension, Premature Birth, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant WomenOther
We want to quantify Minority Americans at risk of pregnancy complications
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Pregnant Women Receives: Other: Pregnant Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy complications as a function of minority status
Pregnancy complications as a function of minority status
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preg Complications: HemorrhagicStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebony Hilton, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145568
- Sponsor's protocol ID
- HSR230385
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris E. US Maternal Mortality Continues to Worsen. JAMA. 2023 Apr 18;329(15):1248. doi: 10.1001/jama.2023.5254. No abstract available.
PubMed 36988993Himmelstein 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.
PubMed 33646291Johnson-Agbakwu CE, Ali NS, Oxford CM, Wingo S, Manin E, Coonrod DV. Racism, COVID-19, and Health Inequity in the USA: a Call to Action. J Racial Ethn Health Disparities. 2022 Feb;9(1):52-58. doi: 10.1007/s40615-020-00928-y. Epub 2020 Nov 16.
PubMed 33197038Boyer BT, Lowell GS, Roehler DR, Quinlan KP. Racial and ethnic disparities of sudden unexpected infant death in large US cities: a descriptive epidemiological study. Inj Epidemiol. 2022 Mar 25;9(1):12. doi: 10.1186/s40621-022-00377-7.
PubMed 35337375
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal & Infant Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT06145568
- Acronym / sponsor ID
- HSR230385
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 24 Nov 2023 (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 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
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: Pregnant WomenPregnant Women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (1 listed)
- pregnant women
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Pregnant WomenWe want to quantify Minority Americans at risk of pregnancy complications | Other | Pregnant Women |
Primary outcome
Pregnancy complications as a function of minority status
Time frame: 10 years
Pregnancy complications as a function of minority status
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 24 Nov 2023.
- Background: PubMed 36988993Harris E. US Maternal Mortality Continues to Worsen. JAMA. 2023 Apr 18;329(15):1248. doi: 10.1001/jama.2023.5254. No abstract available.
- Background: PubMed 33646291Himmelstein 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.
- Background: PubMed 33197038Johnson-Agbakwu CE, Ali NS, Oxford CM, Wingo S, Manin E, Coonrod DV. Racism, COVID-19, and Health Inequity in the USA: a Call to Action. J Racial Ethn Health Disparities. 2022 Feb;9(1):52-58. doi: 10.1007/s40615-020-00928-y. Epub 2020 Nov 16.
- Background: PubMed 35337375Boyer BT, Lowell GS, Roehler DR, Quinlan KP. Racial and ethnic disparities of sudden unexpected infant death in large US cities: a descriptive epidemiological study. Inj Epidemiol. 2022 Mar 25;9(1):12. doi: 10.1186/s40621-022-00377-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Preg Complications: Hemorrhagic and Infant, Premature, Diseases, run by University of Virginia.
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 1 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: opening soon, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Emily Chuang, MA (4349824497, qgz2tk@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy complications as a function of minority status (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145568, which also lists 4 linked publications.
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 24 Nov 2023.