Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

NCT00719654 | Completed

• 1 other identifier: HR # 17495
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

Preeclampsia; Proteome; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Placental tissue will be collected from women affected by EOS-preeclampsia.

  Once, after birth

Study Arms (2)

EOS-Preeclampsia

Women with symptoms of early-onset preeclampsia

Normal

Women who do not have symptoms of early-onset preeclampsia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• weeks completed gestational age

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma and a portion of placenta is retained

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Christopher Robinson, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Donna Johnson

  Medical University of South Carolina, Obstetrics-Gynecology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: July 22, 2008
• Study Start: August 1, 2007
• Primary Completion: April 9, 2012
• Study Completion: April 9, 2012
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

US (1)