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Racial Differences: Nitric Oxide(NO) and Endothelin-1(ET-1) in Preeclampsia (PreE)
This study is currently recruiting participants.
Verified by University of Mississippi Medical Center, November 2008
Sponsors and Collaborators: University of Mississippi Medical Center
Office of Minority Health
Mississippi Institute for Improvement of Geographic Minority Health
Information provided by: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00653809
  Purpose

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.


Condition
Preeclampsia

Drug Information available for: Nitric oxide
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Cross-Sectional
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

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Nitric oxide and Endothelin-1 levels [ Time Frame: 48 hours after tissue collection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nitric oxide isoforms and Endothelin-1 receptor activation based on primary outcome [ Time Frame: within 6 months from tissue collection ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Placental Tissue


Estimated Enrollment: 45
Study Start Date: June 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women delivering babies at the University of MS Medical Center

Criteria

Inclusion Criteria:

  • African-american or Caucasian
  • Pregnant
  • Between ages of 18 - 40 years of age

Exclusion Criteria:

  • Presence of a disease or condition which is not preeclampsia
  • Drug or alcohol abuse during pregnancy
  • Obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653809

Contacts
Contact: Kedra L Wallace, MS 601-984-5311 kwallace2@pharmacology.umsmed.edu
Contact: William A Bennett, PhD 601-984-5301 wbennett@ob-gyn.umsmed.edu

Locations
United States, Mississippi
University of MS Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Kedra L Wallace, MS     601-984-5311     kwallace2@pharmacology.umsmed.edu    
Contact: William A Bennett, PhD     601-984-5301     wbennett@ob-gyn.umsmed.edu    
Principal Investigator: Kedra L Wallace, MS            
Sponsors and Collaborators
University of Mississippi Medical Center
Office of Minority Health
Mississippi Institute for Improvement of Geographic Minority Health
Investigators
Principal Investigator: Kedra L Wallace, MS Obstetrics & Gynecology
  More Information

Responsible Party: University of MS Medical Center ( Kedra Walllace/Researcher IV )
Study ID Numbers: 2007-0065-MIGMH
Study First Received: April 1, 2008
Last Updated: November 12, 2008
ClinicalTrials.gov Identifier: NCT00653809  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Nitric Oxide
Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pregnancy toxemia /hypertension
Pre-Eclampsia
Preeclampsia
Hypertension

Additional relevant MeSH terms:
Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009