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Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT00719654
Recruitment Status : Unknown
Verified July 2008 by Medical University of South Carolina.
Recruitment status was:  Recruiting
First Posted : July 22, 2008
Last Update Posted : July 22, 2008
Information provided by:

Study Description
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.

Condition or disease

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.

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia
Study Start Date : August 2007
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Women with symptoms of early-onset preeclampsia
Women who do not have symptoms of early-onset preeclampsia

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Placental tissue will be collected from women affected by EOS-preeclampsia. [ Time Frame: Once, after birth ]

Biospecimen Retention:   Samples With DNA
Blood plasma and a portion of placenta is retained

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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.

Inclusion Criteria:

  • 20-34 weeks completed gestational age

Exclusion Criteria:

  • Multiple gestation
  • Chronic hypertension
  • Diabetes
  • Lupus
  • Tobacco Use
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719654

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

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
National Center for Research Resources (NCRR)
Principal Investigator: Christopher Robinson, MD Medical University of South Carolina
More Information

Responsible Party: Christopher Robinson, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00719654     History of Changes
Other Study ID Numbers: HR # 17495
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: July 2008

Keywords provided by Medical University of South Carolina:

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