Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00719654
First received: February 19, 2008
Last updated: July 18, 2008
Last verified: July 2008

February 19, 2008
July 18, 2008
August 2007
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00719654 on ClinicalTrials.gov Archive Site
Placental tissue will be collected from women affected by EOS-preeclampsia. [ Time Frame: Once, after birth ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia
Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

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.

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=30) and (2) healthy patients with normal pregnancies (N=120). 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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood plasma and a portion of placenta is retained

Probability Sample

The study population will consist of women who present to MUSC's Women's Health Clinic prior to their 34th week of pregnancy.

Preeclampsia
Not Provided
  • EOS-Preeclampsia
    Women with symptoms of early-onset preeclampsia
  • Normal
    Women who do not have symptoms of early-onset preeclampsia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20-34 weeks completed gestational age

Exclusion Criteria:

  • Multiple gestation
  • Chronic hypertension
  • Diabetes
  • Lupus
  • Tobacco Use
Female
Not Provided
Yes
Contact: Christopher Robinson, MD 8437924500 robinscj@musc.edu
United States
 
NCT00719654
HR # 17495
No
Christopher Robinson, MD, Medical University of South Carolina
Medical University of South Carolina
National Center for Research Resources (NCRR)
Principal Investigator: Christopher Robinson, MD Medical University of South Carolina
Medical University of South Carolina
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP