Obesity Clinical Trial
Official title:
Comparison of Amino-Terminal Pro-Brain Natriuretic Peptide Levels in Healthy Obese and Non-Obese Pregnant Women
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.
This study is a prospective, cross-sectional observational study of pregnant women >=
18-years-old receiving prenatal care through the Duke University Health System. Potential
study subjects will be approached by obstetric providers or by trained research staff at
routine prenatal visits. Approximately 55 subjects will be enrolled, accounting for a
potential 10% loss to follow-up.
Women with pre-pregnancy BMI ≥ 30 will be considered obese, while women with BMI <30 will be
included in the non-obese control group. Extremely obese (BMI≥40), obese (30≤BMI<40),
overweight (25≤BMI<30), and non-obese subjects (BMI<25) will be recruited in a 1:1:1:1
fashion. Subjects will not be matched.
Data collection
Once consent to participate in the study has been obtained and a patient has been deemed
eligible to participate, plasma N-terminal pro-brain natriuretic peptide (collected into a
PST tube), maternal weight, and systolic and diastolic blood pressure will be collected at
the given timepoints:
1. Third-trimester - 27-28 weeks' gestation with third-trimester lab work (CBC, HIV,
glucola)
2. Admission to labor and delivery (for labor, rupture of membranes, or scheduled delivery)
with admission lab work
3. Immediate postpartum: 24-48 hours postpartum
4. Delayed postpartum (4-6 weeks' postpartum to coincide with postpartum visit)
The following additional data will be collected from the electronic medical record: maternal
age, maternal height, maternal pre-pregnancy weight, maternal weight at each time point, best
obstetric estimate of due date, patient-reported race/ethnicity, gravida, para, smoking
status, mode of delivery, delivery date, date of hospital discharge, minimum and maximum
systolic and diastolic blood pressures during labor admission, type of anesthesia used,
hemoglobin and hematocrit at 3rd-trimester lab draw, admission, and immediately postpartum
(if available), and blood loss at delivery. At each visit, subjects will also be questioned
about symptoms and signs of heart failure, including dyspnea on exertion, orthopnea, chest
pain, and lower extremity edema.
PST tubes will be collected by trained research staff at the timepoints listed above. These
will then be sent to the Duke Clinical Lab for analysis, at which point the samples will be
centrifuged and the plasma analyzed for NT-proBNP. NT-proBNP will be analyzed using an
electrochemiluminescence immunoassay on the Roche cobas e411 analyzer.
At each study visit time point, subjects will be asked about any symptoms related to heart
failire. Should they answer yes to any of the questions, the study team will notify their
clinical care team.
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