Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 19, 2008

Last Updated Date

July 18, 2008

Start Date ^†

August 2007

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00719654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Placental tissue will be collected from women affected by EOS-preeclampsia. [ Time Frame: Once, after birth ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

Official Title ^†

Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

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 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 Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Prospective

Condition ^†

Preeclampsia

Intervention ^†

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

150

Estimated Completion Date

August 2010

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

20-34 weeks completed gestational age

Exclusion Criteria:

Multiple gestation
Chronic hypertension
Diabetes
Lupus
Tobacco Use

Gender

Female

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Christopher Robinson, MD

8437924500

robinscj@musc.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00719654

Responsible Party

Christopher Robinson, MD, Medical University of South Carolina

Secondary IDs ^††

Study Sponsor ^†

Medical University of South Carolina

Collaborators ^††

National Center for Research Resources (NCRR)

Investigators ^†

Principal Investigator:

Christopher Robinson, MD

Medical University of South Carolina

Information Provided By

Medical University of South Carolina

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.