Study to Determine if Serum BNP Levels Are Elevated in Pregnant Women With Pre-Eclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00533871
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : September 24, 2007
Information provided by:
Ohio State University

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.

Condition or disease

Detailed Description:

Preeclampsia is a frequent complication of pregnancy. The chief concern is that preeclampsia may progress to end-organ damage, with resultant deterioration of both the mother and the fetus. As a result, women with significant preeclampsia may have their labor accelerated or even require caesarian section. The diagnosis is made based on a constellation of non-specific symptoms, including headache, vision changes, proteinuria, and hypertension. The diagnosis becomes even more difficult to establish when the patient has chronic hypertension prior to her pregnancy.

In many Emergency Departments across the country, emergency physicians are faced with patients that have had either sporadic or non-existent prenatal care. Patients may often not know what their blood pressure was before their pregnancy. Records may not exist or be available for the emergency physician to make an accurate decision. Patients are often transferred to a tertiary care center for obstetrical admission when the diagnosis is unclear, as outlying areas are increasingly without obstetrical coverage. The availability of a sensitive and specific test for the presence of preeclampsia, or gestational hypertension superimposed on chronic hypertension, would allow the emergency physician to avoid costly hospital admissions or transfers while provide safe and effective care for the patient.

B-type or brain type natriuretic peptide (BNP) is a 32-amino acid peptide secreted primarily by the cardiac ventricles under conditions of ventricular wall strain. In addition, it has been demonstrated that BNP is also secreted in the human amnion during pregnancy. Small studies in the international literature suggest that serum BNP is elevated in preeclamptic patients and patients with chronic hypertension in pregnancy. A novel fluorescent immunoassay technique, the Biosite Triage BNP assay, utilizes murine fluorescent labeled antibodies to detect and quantify serum BNP levels. The Triage assay is designed for clinical use, with an estimated laboratory turnaround time of fifteen minutes (Biosite Triage BNP product insert). The Triage assay has gained acceptance as a highly sensitive and specific tool to assist in the rapid diagnosis of congestive heart failure exacerbation; its utility in the preeclamptic population has not been assessed.

Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Utilization of Serum BNP to Distinguish Pre-Eclampsia From Hypertension in Pregnancy
Study Start Date : February 2003
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00533871

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Principal Investigator: Brian C Hiestand, MD Ohio State University Department of Emergency Medicine Identifier: NCT00533871     History of Changes
Other Study ID Numbers: 2003H0020
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: September 24, 2007
Last Verified: September 2007

Keywords provided by Ohio State University:
Natriuretic Peptide Brain

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications