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
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Condition or disease |
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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.
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 |

Group/Cohort |
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EOS-Preeclampsia
Women with symptoms of early-onset preeclampsia
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Normal
Women who do not have symptoms of early-onset preeclampsia
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- 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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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 20-34 weeks completed gestational age
Exclusion Criteria:
- Multiple gestation
- Chronic hypertension
- Diabetes
- Lupus
- Tobacco Use

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 |
Principal Investigator: | Christopher Robinson, MD | Medical University of South Carolina |
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:
Preeclampsia Proteome Pregnancy |
Additional relevant MeSH terms:
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications |