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

BD-STEPS II（评估妊娠暴露的出生缺陷研究）- 核心（组件 A）

• 批准号: 10263869
• 负责人: ALLEN A MITCHELL
• 金额: $ 115万
• 依托单位: MASSACHUSETTS STATE DEPT OF PUB HEALTH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10263869
• 关键词: BD; STEPS; II; Birth; Defects

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.

项目总结/摘要 马萨诸塞州（MA）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分娩的可改变风险因素方面的良好记录 通过参与出生缺陷研究来评估妊娠期缺陷II（BD-STEPS II）。 我们将利用与本地大学的长期合作关系， 未来的出生缺陷研究者MCBDRP为BD-STEPS II带来了我们的专业知识和领导力， 药物流行病学和协作利用独特的数据资源，以适用于所有三个关键 资助机会通知中指定的感兴趣领域。我们的研究将利用现有的数据， 国家出生缺陷预防研究，BD-STEPS I和作为BD-STEPS II的一部分收集的数据。的 MCBDRP调查人员是忠诚和成功的导师和合作伙伴，他们的角色将 在BD-STEPS II中继续并扩展。在五年的资助期内，MCBDRP将至少完成 10个具有公共卫生意义的病原学研究项目，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剂和补充烟酸的潜在预防作用; 2） 检查抗病毒药物，这是预防母婴传播的关键，但对 他们对出生缺陷的安全性; 3）评估已经和将要使用的抗肥胖药物 继续获得FDA的批准，并评估越来越多的减肥手术; 4)调查注意缺陷多动障碍药物，其使用量增加 5）测量多个风险因素之间的复杂关系，以进一步了解 出生缺陷; 6）探索妊娠期药物使用的趋势，以确定相对 7）利用国家实验室的可报告疾病数据库，探索 妊娠前和妊娠期间的感染对出生缺陷的发展; 8）考虑叶酸途径的共同作用， 因子，支持一碳代谢途径，以及它们在神经管发育中的作用; 9） 伴有羊膜带和终末横肢的肢体复位缺陷探讨 缺陷，以了解他们是否有共同的风险因素和发病机制;和10）利用这种独特的 数据来源，以评估新引入药物在妊娠期的相对风险/安全性，这是必不可少的 鉴于在美国没有持续的、系统的方法来监测妊娠期药物安全性。为我们 药物验证试点研究，我们将考虑从最初的处方药 （医疗记录）、药房配药（索赔数据）和母亲使用报告（前瞻性收集的数据 在移动的应用中）。通过这些活动，MCBDRP将成为BD-STEPS II的重要合作伙伴， 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。