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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
  Purpose

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.


Condition
Preeclampsia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Placental tissue will be collected from women affected by EOS-preeclampsia. [ Time Frame: Once, after birth ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood plasma and a portion of placenta is retained


Estimated Enrollment: 150
Study Start Date: August 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
EOS-Preeclampsia
Women with symptoms of early-onset preeclampsia
Normal
Women who do not have symptoms of early-onset 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=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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • 20-34 weeks completed gestational age

Exclusion Criteria:

  • Multiple gestation
  • Chronic hypertension
  • Diabetes
  • Lupus
  • Tobacco Use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719654

Contacts
Contact: Christopher Robinson, MD 8437924500 robinscj@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Christopher Robinson, MD    843-792-4500    robinscj@musc.edu   
Principal Investigator: Christopher Robinson, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Christopher Robinson, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Christopher Robinson, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00719654     History of Changes
Other Study ID Numbers: HR # 17495
Study First Received: February 19, 2008
Last Updated: July 18, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Preeclampsia
Proteome
Pregnancy

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014