Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

Preeclampsia Clinical Trial

Official title:

Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719654
• Other study ID #: HR # 17495
• Status: Completed
• Start date: August 2007
• Est. completion date: April 9, 2012

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: April 9, 2012
• Est. primary completion date: April 9, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 20-34 weeks completed gestational age

Exclusion Criteria:

• Multiple gestation

• Chronic hypertension

• Diabetes

• Lupus

• Tobacco Use

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Placental tissue will be collected from women affected by EOS-preeclampsia.		Once, after birth