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Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT00719654
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date February 19, 2008
First Posted Date July 22, 2008
Last Update Posted Date May 18, 2018
Actual Study Start Date August 2007
Actual Primary Completion Date April 9, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2008)
Blood will be drawn from control patients and EOS-preeclampsia patients to test for differences in proteins between control patients and those with EOS-preeclampsia and differences in the proteins of patients with EOS-preeclampsia before and after birth [ Time Frame: Once prior to and once after birth ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00719654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 18, 2008)
Placental tissue will be collected from women affected by EOS-preeclampsia. [ Time Frame: Once, after birth ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia
Official Title Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia
Brief Summary The hypothesis of this study is that many plasma proteins are altered in concentration and structure in preeclampsia and the elucidation of these alterations will add to the poorly understood pathophysiology of preeclampsia. In this study we will compare the maternal plasma proteomes of early-onset severe preeclampsia versus healthy controls, compare protein expression and quantification of the maternal plasma proteome at the time of diagnosis of EOS-preeclampsia to the plasma proteome of the same affected subject at 48 hours post delivery and we will verify the placental expression of differentially expressed or post-translationally modified proteins found in the plasma of women with EOS-preeclampsia.
Detailed Description

Preeclampsia affects 7-10% of all pregnancies and is directly responsible for 50,000 maternal deaths and 900,000 perinatal deaths each year. Preeclampsia remains unpredictable and incurable except through premature delivery of the fetus. It is essential that a better understanding of preeclampsia is obtained.

Proteomics offers a methodology for identification and quantification of each protein fraction found in human plasma in both disease and health. Since proteins are the basic elements of human biology, it is anticipated that alterations in protein posttranslational modification or total protein expression would be indicative and diagnostic of a disease state. Because proteins are recognized to act as messengers through hormone action, act as enzymes to catalyze important organic reactions and serve as structural components of the human body, they are the most representative of the current state of metabolic and structural activity in both the naive and disease state.

Two groups of patients will be enrolled: (1) Patients with EOS-preeclampsia (N=60) and (2) healthy patients with normal pregnancies (N=240). The patients with EOS-preeclampsia will be matched (1:4) with contemporaneous control patients who are carrying a singleton gestation at a similar gestational age. To measure changes in proteins, we will compare proteins in the blood plasma of women with EOS-preeclampsia before and after pregnancy. We will also compare the blood plasmas of healthy versus EOS-preeclamptic women for differences in plasma proteins. Finally, we will examine the placental RNA of patients with EOS-preeclampsia and healthy patients delivered at 35-37 weeks gestation.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood plasma and a portion of placenta is retained
Sampling Method Probability Sample
Study Population The study population will consist of women who present to MUSC's Women's Health Clinic prior to their 34th week of pregnancy.
Condition Preeclampsia
Intervention Not Provided
Study Groups/Cohorts
  • EOS-Preeclampsia
    Women with symptoms of early-onset preeclampsia
  • Normal
    Women who do not have symptoms of early-onset preeclampsia
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: May 15, 2018)
316
Original Estimated Enrollment
 (submitted: July 18, 2008)
150
Actual Study Completion Date April 9, 2012
Actual Primary Completion Date April 9, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 20-34 weeks completed gestational age

Exclusion Criteria:

  • Multiple gestation
  • Chronic hypertension
  • Diabetes
  • Lupus
  • Tobacco Use
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00719654
Other Study ID Numbers HR # 17495
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor Medical University of South Carolina
Collaborators National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Christopher Robinson, MD Medical University of South Carolina
Study Chair: Donna Johnson Medical University of South Carolina, Obstetrics-Gynecology
PRS Account Medical University of South Carolina
Verification Date May 2018