Comparison of Amino-Terminal Pro-Brain Natriuretic Peptide Levels in Healthy Obese and Non-Obese Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- NT-proBNP
研究概览
简要总结
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.
详细描述
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:
- Third-trimester - 27-28 weeks' gestation with third-trimester lab work (CBC, HIV, glucola)
- Admission to labor and delivery (for labor, rupture of membranes, or scheduled delivery) with admission lab work
- Immediate postpartum: 24-48 hours postpartum
- Delayed postpartum (4-6 weeks' postpartum to coincide with postpartum visit)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
NT-proBNP
时间窗: 4-6 week postpartum visit
NT-proBNP levels in pregnancy across BMI categories
次要结局
未报告次要终点
