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Trial record 8 of 232 for:    EDN1

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

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ClinicalTrials.gov Identifier: NCT00653809
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : April 6, 2012
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

Tracking Information
First Submitted Date April 1, 2008
First Posted Date April 7, 2008
Last Update Posted Date April 6, 2012
Study Start Date June 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2008)
Nitric oxide and Endothelin-1 levels [ Time Frame: 48 hours after tissue collection ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00653809 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 4, 2008)
Nitric oxide isoforms and Endothelin-1 receptor activation based on primary outcome [ Time Frame: within 6 months from tissue collection ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Racial Differences: Nitric Oxide(NO) and Endothelin-1(ET-1) in Preeclampsia (PreE)
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
Brief 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. With this information it might be possible to intervene with approved pharmacological treatments.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Placental Tissue
Sampling Method Non-Probability Sample
Study Population Women delivering babies at the University of MS Medical Center
Condition Preeclampsia
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2012)
52
Original Estimated Enrollment
 (submitted: April 4, 2008)
45
Actual Study Completion Date September 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00653809
Other Study ID Numbers 2007-0065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kedra Wallace, University of Mississippi Medical Center
Study Sponsor University of Mississippi Medical Center
Collaborators
  • Office of Minority Health
  • Mississippi Institute for Improvement of Geographic Minority Health
Investigators
Principal Investigator: Kedra L Wallace, PhD Obstetrics & Gynecology
PRS Account University of Mississippi Medical Center
Verification Date April 2012