- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324402
Plasma Brain Natriuretic Peptide Levels in Pregnancy
October 1, 2020 updated by: Oklahoma State University Center for Health Sciences
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oklahoma
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Tulsa, Oklahoma, United States, 74127
- Oklahoma State University Center for Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy pregnant women, 18-40
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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1
Healthy pregnant women, 18-40
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
May 9, 2006
First Submitted That Met QC Criteria
May 10, 2006
First Posted (Estimate)
May 11, 2006
Study Record Updates
Last Update Posted (Actual)
October 5, 2020
Last Update Submitted That Met QC Criteria
October 1, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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