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Racial Differences: Nitric Oxide(NO) and Endothelin-1(ET-1) in Preeclampsia (PreE)

This study has been completed.
Sponsor:
Collaborators:
Office of Minority Health
Mississippi Institute for Improvement of Geographic Minority Health
Information provided by (Responsible Party):
Kedra Wallace, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00653809
First received: April 1, 2008
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Placental Tissue


Enrollment: 52
Study Start Date: June 2007
Study Completion Date: September 2009
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

Locations
United States, Mississippi
University of MS Medical Center
Jackson, Mississippi, United States, 39216
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, PhD Obstetrics & Gynecology
  More Information

No publications provided

Responsible Party: Kedra Wallace, Postdoc Research Fellow, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00653809     History of Changes
Other Study ID Numbers: 2007-0065
Study First Received: April 1, 2008
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013