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Plasma Brain Natriuretic Peptide Levels in Pregnancy

This study has been completed.

Sponsored by: Oklahoma State University Center for Health Sciences
Information provided by: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00324402
  Purpose

To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the second and third trimesters of a normal pregnancy. We will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology.


Condition
Cardiomyopathy
Pregnancy

MedlinePlus related topics:   Cardiomyopathy   

ChemIDplus related topics:   Nesiritide   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Plasma Brain Natriuretic Peptide Levels in Pregnancy

Further study details as provided by Oklahoma State University Center for Health Sciences:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   50
Study Start Date:   August 2006
Study Completion Date:   June 2008

Groups/Cohorts
1
Healthy pregnant women, 18-40

Detailed Description:

The brain natriuretic peptide (BNP) is a useful marker for volume overload, increased filling pressures and stretching of the myocardium. The current literature contains limited and unreliable information regarding normal BNP values in pregnancy. After baseline echocardiogram to detect individuals with asymptomatic structural defects, the participants will submit to 3 blood draws during the second and third trimester and at delivery to determine normal pregnancy values.

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Healthy pregnant women, 18-40


Criteria

Inclusion Criteria:

  • women age 18 to 40
  • second trimester of pregnancy

Exclusion Criteria:

  • known cardiac or valvular disease,
  • atrial fibrillation or other arrhythmia,
  • pulmonary hypertension,
  • chronic hypertension,
  • hypertensive disorders of pregnancy,
  • morbid obesity (BMI > 40 kg/meter squared)
  • history of sleep apnea
  • multiple gestation
  • known renal dysfunction
  • medications known to affect cardiac function
  • current or past abnormal echocardiogram
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324402

Locations
United States, Oklahoma
Oklahoma State University Center for Health Sciences    
      Tulsa, Oklahoma, United States, 74127

Sponsors and Collaborators
Oklahoma State University Center for Health Sciences

Investigators
Study Chair:     Kimberly A Sorensen, DO     Oklahoma State University Center for Health Sciences    
Principal Investigator:     John M Beal, DO     Oklahoma State University Center for Health Sciences    
  More Information


Responsible Party:   Oklahoma State University Center for Health Sciences ( Dr. J. Martin Beal, assistant professor of Ob/Gyn )
Study ID Numbers:   2005008
First Received:   May 9, 2006
Last Updated:   July 8, 2008
ClinicalTrials.gov Identifier:   NCT00324402
Health Authority:   United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
brain natriuretic peptide  
pregnancy  
biomarker  

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Diseases
Cardiomyopathies

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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