NCT00533871

Brief Summary

Preeclampsia is a common disease state occurring in the third trimester of pregnancy, with an incidence of approximately 5-10% in the US. Hypertension (high blood pressure), a primary symptom of pre-eclampsia, may be present in women who were hypertensive prior to becoming pregnant.B-type (also known as brain) natriuretic peptide (BNP) is known to be made and released from the heart ventricles when the heart is strained. There is also evidence that BNP is secreted in the placenta, and may increase in preeclampsia and chronic hypertension in pregnancy.The purpose of the study is to determine if a maternal blood sample analyzed for the quantity of BNP is helpful in differentiating between pre-eclampsia and chronic high blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2003

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

February 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

September 21, 2007

Last Update Submit

September 21, 2007

Conditions

Keywords

Natriuretic Peptide Brain

Study Arms (3)

Normotensive

Pregnant women in the third trimester with normal blood pressure this pregnancy and no history of HTN or pre-eclampsia in a previous pregnancy

Chronic Hypertensive

Pregnant women in their third trimester with known hypertension prior to the current pregnancy

Pre-eclampsia

Pregnant women in their third trimester who meet ACOG diagnostic criteria for pre-eclampsia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women age 18 or older at 34 or more weeks of pregnancy
  • Control arm:normal blood pressure during pregnancy
  • Chronic HTN arm: known to have HTN predating this gestation
  • Pre-eclampsia arm:meet ACOG diagnostic criteria for pre-eclampsia this pregnancy and present to labor and delivery for evaluation and/ or treatment

You may not qualify if:

  • minors, prisoners,unable to provide consent
  • multiple gestation
  • currently in labor
  • Control arm:presence of hypertension, a history of gestational hypertension, current therapy with an anti-hypertensive medication, any history of congestive heart failure
  • Chronic HTN arm:evidence of superimposed preeclampsia at the time of enrollment (headache, proteinuria, peripheral edema, or visual changes), any history of congestive heart failure
  • Pre-eclampsia arm:history of congestive heart failure, pretreatment with anti-hypertensive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brian C Hiestand, MD

    Ohio State University Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 24, 2007

Study Start

February 1, 2003

Study Completion

June 1, 2005

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations