PreeclampsiaNCT00653809
Racial Differences: Nitric Oxide(NO) and Endothelin-1(ET-1) in Preeclampsia (PreE)
An observational study of Preeclampsia, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The goal of this study is to examine the activation of markers of endothelial and cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this study will hopefully provide enough information to determine a link between race, the advent of high risk pregnancies and cardiovascular markers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women delivering babies at the University of MS Medical Center
Who may be able to join
- African-american or Caucasian
- Pregnant
- Between ages of 18 - 40 years of age
Who cannot join
- Presence of a disease or condition which is not preeclampsia
- Drug or alcohol abuse during pregnancy
- Obesity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of MS Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Elucidating the Role of Nitric Oxide and Endothelin-1 Activation in Endothelial Cells Co-cultured With Placental Explants From African-american and Caucasian High Risk Pregnancies
The goal of this study is to examine the activation of markers of endothelial and cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this study will hopefully provide enough information to determine a link between race, the advent of high risk pregnancies and cardiovascular markers. With this information it might be possible to intervene with approved pharmacological treatments.
- Conditions
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A, 1, I | Caucasian women without preeclampsia or PIH, delivering their first child | |
| A, 1, II | Caucasian women with preeclampsia or PIH, delivering their first child | |
| A, 2, I | African-american women without preeclampsia or PIH, delivering their first child | |
| A, 2, II | African-American women with preeclampsia or PIH, delivering their first child | |
| B, 1, I | Caucasian women without preeclampsia or PIH, delivering at least their second child | |
| B, 1, II | Caucasian women with preeclampsia or PIH, delivering at least their second child | |
| B, 2, I | African-american women without preeclampsia or PIH, delivering at least their second child | |
| B, 2, II | African-american women with preeclampsia or PIH, delivering at least their second child |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nitric oxide and Endothelin-1 levels
Measured: 48 hours after tissue collection
Secondary outcomes (1)
Nitric oxide isoforms and Endothelin-1 receptor activation based on primary outcome
Measured: within 6 months from tissue collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Minority Health, Mississippi Institute for Improvement of Geographic Minority Health
- Responsible party
- Principal investigator, Kedra Wallace, University of Mississippi Medical Center
- Investigators
- Kedra L Wallace, PhD, Principal investigator, Obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653809
- Sponsor's protocol ID
- 2007-0065
- Status last verified
- Apr 2012
- First submitted
- 1 Apr 2008
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Role of Nitric Oxide and Endothelin-1 Activation in Endothelial Cells Co-cultured With Placental Explants From African-american and Caucasian High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT00653809
- Acronym / sponsor ID
- 2007-0065
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Office of Minority Health, Mississippi Institute for Improvement of Geographic Minority Health
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 Apr 2008 (estimated)
- 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 goal of this study is to examine the activation of markers of endothelial and cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this study will hopefully provide enough information to determine a link between race, the advent of high risk pregnancies and cardiovascular markers. With this information it might be possible to intervene with approved pharmacological treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A, 1, I | – | –Caucasian women without preeclampsia or PIH, delivering their first child |
| A, 1, II | – | –Caucasian women with preeclampsia or PIH, delivering their first child |
| A, 2, I | – | –African-american women without preeclampsia or PIH, delivering their first child |
| A, 2, II | – | –African-American women with preeclampsia or PIH, delivering their first child |
| B, 1, I | – | –Caucasian women without preeclampsia or PIH, delivering at least their second child |
| B, 1, II | – | –Caucasian women with preeclampsia or PIH, delivering at least their second child |
| B, 2, I | – | –African-american women without preeclampsia or PIH, delivering at least their second child |
| B, 2, II | – | –African-american women with preeclampsia or PIH, delivering at least their second child |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women delivering babies at the University of MS Medical Center
Key inclusion criteria (3 listed)
- African-american or Caucasian
- Pregnant
- Between ages of 18 - 40 years of age
Key exclusion criteria (3 listed)
- Presence of a disease or condition which is not preeclampsia
- Drug or alcohol abuse during pregnancy
- Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nitric oxide and Endothelin-1 levels
Time frame: 48 hours after tissue collection
1 secondary outcome
Nitric oxide isoforms and Endothelin-1 receptor activation based on primary outcome
Time frame: within 6 months from tissue collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Type 1 Diabetes, Preeclampsia
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Severe Preeclampsia
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.
Kedra L Wallace, PhD principal investigator
Obstetrics & Gynecology
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 Preeclampsia, run by University of Mississippi Medical Center 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 6 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nitric oxide and Endothelin-1 levels (time frame: 48 hours after tissue collection). 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 6 Apr 2012.