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
|Condition or disease|
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|
|Actual Enrollment :||316 participants|
|Official Title:||Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia|
|Actual Study Start Date :||August 2007|
|Actual Primary Completion Date :||April 9, 2012|
|Actual Study Completion Date :||April 9, 2012|
Women with symptoms of early-onset preeclampsia
Women who do not have symptoms of early-onset preeclampsia
- 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 ]
- Placental tissue will be collected from women affected by EOS-preeclampsia. [ Time Frame: Once, after birth ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719654
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Christopher Robinson, MD||Medical University of South Carolina|
|Study Chair:||Donna Johnson||Medical University of South Carolina, Obstetrics-Gynecology|