Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

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.

Study Overview

• Status: Completed
• Conditions: 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=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
• Enrollment (Actual): 316

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study population will consist of women who present to MUSC's Women's Health Clinic prior to their 34th week of pregnancy.

Description

Inclusion Criteria:

• 20-34 weeks completed gestational age

Exclusion Criteria:

• Multiple gestation
• Chronic hypertension
• Diabetes
• Lupus
• Tobacco Use

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EOS-Preeclampsia; Women with symptoms of early-onset preeclampsia
Normal; Women who do not have symptoms of early-onset preeclampsia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Once prior to and once after birth

Secondary Outcome Measures

Outcome Measure	Time Frame
Placental tissue will be collected from women affected by EOS-preeclampsia.	Once, after birth

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Christopher Robinson, MD, Medical University of South Carolina; Study Chair: Donna Johnson, Medical University of South Carolina, Obstetrics-Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): April 9, 2012
• Study Completion (Actual): April 9, 2012

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; Preeclampsia; Proteome
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: HR # 17495