Pregnancy outcomes and asthma medications in pregnancy: a Demonstration Project

妊娠结局和妊娠期哮喘药物：示范项目

• 批准号: 8118426
• 负责人: CHRISTINA CHAMBERS
• 金额: $ 48.96万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8118426
• 关键词: Pregnancy; outcomes; asthma; medications; pregnancy

DESCRIPTION (provided by the applicant): Despite the fact that asthma and allergy represent the most common conditions for which pregnant women take prescription medications, there is no systematic approach to evaluating the relative risks and safety of these medications with respect to pregnancy outcomes. Such information is critically needed for prescribers to make meaningful risk benefit assessments of these widely used medications and for patients to feel comfortable that the potential adverse effects associated with the drugs prescribed for them have been adequately studied. To fill this critical gap in clinical knowledge, we propose to demonstrate the feasibility of a comprehensive and ongoing system to assess the relative safety of asthma medications in pregnancy. This specific application will demonstrate the feasibility of using an established cohort pregnancy outcome study design (Organization of Teratology Information Specialists or OTIS), to generate and test hypotheses related to the comparative risk (or safety) for birth defects overall, preterm delivery, small-for-gestational age infants, and perinatal complications associated with recently introduced asthma medications for which there is little to no current data. In addition, this demonstration project will integrate the findings of the cohort study with data derived from a parallel and complementary case-control demonstration application submitted by the Slone Epidemiology Center's Birth Defects Study. Finally, this demonstration project will work in close collaboration with the American Academy of Asthma, Allergy, and Immunology (AAAAI) to develop the infrastructure for an ongoing comparative pregnancy safety system. This will include an expert independent advisory committee to evaluate the accumulating data from the OTIS cohort study as well as case-control data, and to offer recommendations regarding relative risk and safety of asthma medications in pregnancy. These three activities taken together will further demonstrate the feasibility of the system for studying comparative safety of other recently marketed and/or commonly used medications in pregnancy.

描述（由申请方提供）：尽管哮喘和过敏是孕妇服用处方药的最常见疾病，但尚无系统方法评价这些药物对妊娠结局的相对风险和安全性。这些信息对于处方者对这些广泛使用的药物进行有意义的风险获益评估以及患者感到舒适是非常必要的，因为为他们开具的药物相关的潜在不良反应已经得到了充分的研究。为了填补临床知识的这一关键空白，我们建议证明一个全面和持续的系统来评估妊娠期哮喘药物的相对安全性的可行性。该特定应用将证明使用既定队列妊娠结局研究设计（畸形学信息专家组织或奥蒂斯）的可行性，以生成和检验与近期引入的哮喘药物相关的出生缺陷总体、早产、小于胎龄儿和围产期并发症的比较风险（或安全性）相关的假设，目前几乎没有相关数据。此外，该示范项目将把队列研究的结果与来自斯隆流行病学中心出生缺陷研究提交的平行和补充病例对照示范申请的数据相结合。最后，该示范项目将与美国哮喘、过敏和免疫学学会（AAAAI）密切合作，为正在进行的比较妊娠安全系统开发基础设施。这将包括一个专家独立咨询委员会，以评估来自奥蒂斯队列研究的累积数据以及病例对照数据，并提供关于妊娠期哮喘药物的相对风险和安全性的建议。这三项活动将进一步证明该系统用于研究其他最近上市和/或常用妊娠药物的比较安全性的可行性。