B-WELL-Mom Study

美国西北大学和阿拉巴马大学伯明翰分校B-WELL-Mom临床中心共招募了418名患者，其中包括311名哮喘患者（147名哮喘控制良好，164名哮喘控制欠佳）和107名无哮喘的孕妇。哮喘控制评估将基于NHLBI专家小组报告中描述的标准。除哮喘病史问题外，对照受试者遵循相同的方案。所有患者将进行四次临床研究访问。在每次就诊时，临床评估将包括血压、脉搏血氧饱和度、峰值血流、FEV1和FEV6。生物标本也将被收集。患者填写与哮喘或呼吸问题加重或缓解的症状和危险因素相关的问卷。流式细胞术将用于计数免疫细胞，包括t调节细胞。所有临床数据收集程序都是建立良好的程序，风险最小，研究调查基于预先存在的有效问卷。在两次就诊之间，女性将记录她们的峰值血流，呼出一氧化氮，并回答有关症状、药物和其他可能干扰呼吸的因素的问题。医疗记录审查将记录急诊和住院情况，以及分娩和分娩的细节。

The B-WELL-Mom clinical centers, Northwestern University and the University of Alabama Birmingham, have recruited a total of 418 patients including 311 asthmatics (147 with well-controlled asthma and 164 with sub-optimal asthma control) and 107 women without asthma from their prenatal clinic populations. Asthma control assessment will be based on the criteria described in the NHLBI expert panel report. Except for asthma history questions, control subjects follow the same protocol. All patients will have four study clinic visits. At each visit, clinical assessments will include blood pressure, pulse oximetry, peak flow, FEV1 and FEV6. Biologic specimens will also be collected. Patients complete questionnaires related to symptoms and risk factors for exacerbation or mediation of asthma or breathing problems. Flow cytometry will be conducted to count immune cells including T-regulatory cells. All of the clinical data collection procedures are well-established procedures with minimal risk and the study surveys are based on preexisting, validated questionnaires. Between clinic visits, women will record their peak flow, exhaled nitric oxide and answer questions on symptoms, medications and other factors that might interfere with breathing. Medical record review will capture emergency visits and hospitalizations as well as details of labor and delivery.