NT-proBNP Levels and Obesity in Pregnancy
关键词
抽象
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:
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.
日期
最后验证: | 07/31/2019 |
首次提交: | 08/05/2019 |
提交的预估入学人数: | 08/05/2019 |
首次发布: | 08/06/2019 |
上次提交的更新: | 08/05/2019 |
最近更新发布: | 08/06/2019 |
实际学习开始日期: | 07/14/2019 |
预计主要完成日期: | 06/29/2020 |
预计完成日期: | 06/29/2020 |
状况或疾病
干预/治疗
Diagnostic Test: NT-proBNP
相
手臂组
臂 | 干预/治疗 |
---|---|
Healthy pregnant women with BMI <30 | |
Healthy pregnant women with BMI >=30 |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | Female |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. NT-proBNP [27-29 weeks]
2. NT-proBNP [delivery admission]
3. NT-proBNP [24-48 hours postpartum]
4. NT-proBNP [4-6 week postpartum visit]