Ignite Creation Date:
2024-05-05 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00719654
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2008-02-19
Brief Title:
Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Preeclampsia affects 7-10 of all pregnancies and is directly responsible for 50000 maternal deaths and 900000 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 N60 and 2 healthy patients with normal pregnancies N240 The patients with EOS-preeclampsia will be matched 14 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
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 N60 and 2 healthy patients with normal pregnancies N240 The patients with EOS-preeclampsia will be matched 14 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None