Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia
Recruitment status was Recruiting
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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 |
|---|
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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 |
- 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 ]
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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 March 03, 2015