BD-STEPS II (Birth Defects Study To Evaluate Pregnancy exposures) - Core (Component A) & Steps Stillbirth (Component B)

项目摘要/摘要 马萨诸塞州出生缺陷研究和预防中心(MCBDRP)建议继续 它在进行病因学研究以确定结构性出生的可改变的风险因素方面有着良好的记录 通过参与出生缺陷研究来评估怀孕暴露情况二(BD-STEPS II)。 我们将通过利用我们与当地大学的长期关系来加强我们的贡献 未来的出生缺陷研究人员。MCBDRP为BD-STEP II带来了我们在以下方面的专业知识和领导地位 药物流行病学和独特数据资源的协作利用将应用于所有三个关键字 融资机会通知中列出的感兴趣的领域。我们的研究将利用现有的数据 国家出生缺陷预防研究，BD-步骤I和作为BD-步骤II的一部分收集的数据。 MCBDRP调查人员是忠诚而成功的导师和合作伙伴，这些角色将 在BD-Steps II内继续和扩大。在五年赠款期间，MCBDRP将至少完成 10个具有公共卫生意义的病因学研究项目，将有助于咨询妇女考虑 不太可能导致出生缺陷的暴露；这些项目包括：1)评估烟酰胺 腺嘌呤二核苷酸途径抑制物与补充烟酸的潜在预防作用 检查抗病毒药物，这些药物是防止母婴传播的关键，但对此知之甚少 他们在出生缺陷方面的安全性；3)评估已经和将会使用的减肥药物 继续得到FDA的批准，并评估越来越多的减肥外科手术； 4)调查注意力缺陷多动障碍药物，这些药物的使用有所增加 显著；5)衡量多种风险因素之间的复杂关系，以加深我们对 出生缺陷；6)探索怀孕期间药物使用的趋势，以确定哪些药物正在变得相对 通常用于怀孕；7)利用国家实验室的可报告疾病数据库来探索 孕前和孕期感染对出生缺陷发生的影响；8)考虑叶酸途径 支持一碳代谢途径的因素及其在神经管发育中的作用；9) 探讨伴有羊膜带和终末横肢的肢体缩短症 缺陷，以了解它们是否具有共同的风险因素和发病机制；以及利用这一独特的 评估新引进药物在妊娠中的相对风险/安全性的数据来源，这是必不可少的 鉴于美国没有持续的、系统的方法来监测怀孕期间的药物安全。为我们的 药物验证试点研究我们将考虑从最初的处方中提取的处方药 (医疗记录)、药房配药(索赔数据)和母亲使用报告(预期收集的数据 在移动应用程序中)。通过这些活动，MCBDRP将成为BD的重要合作伙伴--步骤二至 实现我们的总体目标，将研究成果转化为预防出生缺陷的有意义的举措。

Project Summary / Abstract The Massachusetts (MA) Center for Birth Defects Research and Prevention (MCBDRP) proposes to continue its strong track record of conducting etiologic research to identify modifiable risk factors for structural birth defects through its participation in the Birth Defects Study to Evaluate Pregnancy exposureS II (BD-STEPS II). We will enhance our contributions by leveraging our longstanding relationship with local universities to produce future birth defects researchers. The MCBDRP brings to BD-STEPS II our expertise and leadership in pharmacoepidemiology and collaborative utilization of unique data resources to be applied to all three key areas of interest named in the Notice of Funding Opportunity. Our research will utilize existing data from the National Birth Defects Prevention Study, BD-STEPS I and data to be collected as part of BD-STEPS II. The MCBDRP investigators are committed and successful mentors and collaborative partners, roles that will continue and expand within BD-STEPS II. Over the five year grant period, the MCBDRP will complete at least 10 etiologic research projects of public health significance that will aid in counseling women in considering exposures that are less likely to result in a birth defect; these projects include: 1) Evaluating nicotinamide adenine dinucleotide pathway inhibitors and the potential preventive effect of supplementation with niacin; 2) Examining anti-viral medications, which are key to preventing maternal-fetal transmission but little is known on their safety with respect to birth defects; 3) Assessing anti-obesity medications that have been and will continue to be approved by FDA and assessing bariatric surgical procedures that are increasingly performed; 4) Investigating attention deficit hyperactivity disorder medications, the use of which has increased dramatically; 5) Gauging the complex relationship among multiple risk factors to further our understanding of birth defects; 6) Exploring trends in medication use in pregnancy to identify drugs that are becoming relatively commonly used in pregnancy; 7) Leveraging the State Lab's reportable disease database to explore the role of infections before and during pregnancy on the development of birth defects; 8) Considering folate pathway co- factors, that support the one-carbon metabolism pathway, and their role in neural tube development; 9) Exploring limb reduction deficiencies that are accompanied by amniotic bands and terminal transverse limb defects to understand if they share common risk factors and pathogenesis; and 10) Harnessing this unique data source to assess the relative risks/safety in pregnancy of newly-introduced medications, which is essential given there is no ongoing, systematic approach to monitor drug safety in pregnancy in the US. For our medication validation pilot study we will consider prescription drugs derived from the initial prescription (medical record), pharmacy dispensing (claims data) and maternal report of use (prospectively collected data in a mobile application). Through these activities, the MCBDRP will be an essential partner in BD-STEPS II to achieve our overall goal of translating research findings into meaningful initiatives in birth defects prevention.