NCT00653809

Brief Summary

The goal of this study is to examine the activation of markers of endothelial and cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this study will hopefully provide enough information to determine a link between race, the advent of high risk pregnancies and cardiovascular markers. With this information it might be possible to intervene with approved pharmacological treatments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

1.5 years

First QC Date

April 1, 2008

Last Update Submit

April 5, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Nitric oxide and Endothelin-1 levels

    48 hours after tissue collection

Secondary Outcomes (1)

  • Nitric oxide isoforms and Endothelin-1 receptor activation based on primary outcome

    within 6 months from tissue collection

Study Arms (8)

A, 1, I

Caucasian women without preeclampsia or PIH, delivering their first child

A, 1, II

Caucasian women with preeclampsia or PIH, delivering their first child

A, 2, I

African-american women without preeclampsia or PIH, delivering their first child

A, 2, II

African-American women with preeclampsia or PIH, delivering their first child

B, 1, I

Caucasian women without preeclampsia or PIH, delivering at least their second child

B, 1, II

Caucasian women with preeclampsia or PIH, delivering at least their second child

B, 2, I

African-american women without preeclampsia or PIH, delivering at least their second child

B, 2, II

African-american women with preeclampsia or PIH, delivering at least their second child

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women delivering babies at the University of MS Medical Center

You may qualify if:

  • African-american or Caucasian
  • Pregnant
  • Between ages of 18 - 40 years of age

You may not qualify if:

  • Presence of a disease or condition which is not preeclampsia
  • Drug or alcohol abuse during pregnancy
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of MS Medical Center

Jackson, Mississippi, 39216, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Placental Tissue

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kedra L Wallace, PhD

    Obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc Research Fellow

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 7, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2008

Study Completion

September 1, 2009

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations