Obesity Clinical Trial
Official title:
Comparison of Amino-Terminal Pro-Brain Natriuretic Peptide Levels in Healthy Obese and Non-Obese Pregnant Women
NCT number | NCT04049136 |
Other study ID # | PRO00101213 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2019 |
Est. completion date | July 1, 2020 |
Verified date | August 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A screening modality to help categorize obese pregnant women as high or low probability for
heart failure would be helpful in the evaluation of the obese pregnant women with dyspnea.
Outside of pregnancy, measurement of brain natriuretic peptide (BNP) or amino-terminal
pro-brain natriuretic peptide (NT-proBNP) is recommended in the evaluation of acute dyspnea
and in the diagnosis of heart failure. During pregnancy, elevated BNP has been associated
with adverse cardiovascular events, while normal BNP levels have been observed in healthy
pregnancies. While BNP levels outside of pregnancy have been shown to be lower in obese
patients variations in BNP levels by body mass index (BMI) in pregnancy have not been
studied. Before BNP can be deemed a reliable screening test for heart failure in obese
pregnant women, normal BNP values in the setting of obesity and pregnancy need to be
established. We therefore propose the following specific aims:
Objective 1: Compare mean plasma NT-proBNP levels in the third trimester, immediately
postpartum, and at 4-6 weeks postpartum between obese pregnant women without cardiovascular
disease and non-obese pregnant women without cardiovascular disease. We hypothesize that mean
plasma NT-proBNP levels in obese pregnant women without pre-existing cardiovascular disease
will be significantly lower than levels in non-obese pregnant women.
Objective 2: Assess whether plasma NT-proBNP levels in pregnancy correlate with BMI. We
hypothesize that there will be an inverse correlation between plasma NT-proBNP levels and BMI
in our pregnant cohort similar to that seen outside of pregnancy.
Status | Completed |
Enrollment | 56 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Eligibility criteria Third-trimester pregnancy (=27 weeks) Exclusion criteria Age = 18 years English-speaking Fetal complications - Fetal anomalies - Intrauterine fetal demise - Fetal growth restriction (<5%ile) - Fetal aneuploidy Maternal complications - Chronic hypertension (diagnosis pre-dating pregnancy or BP =140/90 at <20 weeks gestation) - Autoimmune disorders (systemic lupus erythematosus, rheumatoid arthritis, Sjogren's) - Baseline renal disease (baseline Cr >1.0) - Pre-existing diabetes mellitus - History of cardiomyopathy or heart failure - History of cardiac arrest or myocardial infarction |
Country | Name | City | State |
---|---|---|---|
United States | Duke Perinatal Durham Clinic | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NT-proBNP | NT-proBNP levels in pregnancy across BMI categories | 27-29 weeks | |
Primary | NT-proBNP | NT-proBNP levels in pregnancy across BMI categories | delivery admission | |
Primary | NT-proBNP | NT-proBNP levels in pregnancy across BMI categories | 24-48 hours postpartum | |
Primary | NT-proBNP | NT-proBNP levels in pregnancy across BMI categories | 4-6 week postpartum visit |
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