Massachusetts Center for Birth Defects Research and Prevention

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孕期暴露(BD-STEPS)。我们 将通过利用我们已经建立的培训计划来提高我们的贡献，该计划旨在产生 未来的出生缺陷研究人员。MCBDRP为BD-Steps带来了我们在以下领域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四个关键领域 在融资机会公告中被点名。我们的研究将利用国家统计局的现有数据 出生缺陷预防研究，作为BD-STEP的一部分收集的数据和我们独有的数据集 协作团队，包括怀孕到早期生活纵向数据库，MA结果研究 辅助生殖技术，斯隆流行病学中心的多点出生缺陷研究，以及 北美抗癫痫药物怀孕登记处。MCBDRP调查人员致力于并取得成功 导师和协作伙伴，这些角色将在BD-Steps中继续和扩展。在过去五年中 在授权期内，MCBDRP将完成至少10个具有重要医学意义的病因学研究项目 与出生缺陷风险有关的常见暴露包括：1)口服糖尿病药物，更多 随着糖尿病患病率的增加而常见；2)抗肥胖药物，这给了目前 肥胖增加已经并将继续得到FDA的批准；3)治疗肥胖的药物和程序 治疗不孕不育症，这是一个MA提供独特优势的领域，因为大量的老年母亲和高龄女性 利用辅助生殖技术(ART)；4)含有内分泌干扰物的药物 邻苯二甲酸盐，这将是提议研究药物中更多非活性成分的典范；5) 抗癫痫药物，包括研究增加出生缺陷风险的遗传因素；6)非 类固醇抗炎药，很重要，因为超过20%的孕妇使用它们；7) 治疗妊娠恶心和呕吐的药物，关键是因为一些药物的使用越来越多 妊娠特定情况；8)出生缺陷的时空聚集，表明环境或 感染病因学，包括扩大我们在腹裂方面的工作和扩大研究 其他出生缺陷的方法学；9)抗抑郁药，特别是选择性5-羟色胺再摄取抑制剂， 包括与特定药物有关的效应调节剂和基因决定的预测因子；以及10)药物 在怀孕期间服用，包括非处方药产品，并通过定期筛查BD步骤 数据，识别可能构成风险的新产品。通过这些活动，MCBDRP将是一个必不可少的 BD中的合作伙伴-实现将研究成果转化为有意义的预防的总体目标的步骤 首创精神。

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 (BD-STEPS). We will enhance our contributions by leveraging our already established training program designed to produce future birth defects researchers. MCBDRP brings to BD-STEPS our expertise and leadership in pharmacoepidemiology and collaborative utilization of unique data resources to be applied to all four key areas named in the Funding Opportunity Announcement. Our research will utilize existing data from the National Birth Defects Prevention Study, data to be collected as part of BD-STEPS and data sets unique to our collaborative team including the Pregnancy to Early Life Longitudinal database, the MA Outcomes Study of Assisted Reproductive Technologies, the Slone Epidemiology Center's multi-site Birth Defects Study, and the North American Antiepileptic Drug Pregnancy Registry. MCBDRP investigators are committed and successful mentors and collaborative partners, roles that will continue and expand within BD-STEPS. Over the five year grant period, the MCBDRP will complete at least 10 etiologic research projects that cover medically significant and common exposures as they relate to risks of birth defects including: 1) Oral diabetic medications, more common as the prevalence of diabetes increases; 2) Anti-obesity medications, which given the current increase in obesity have been and will continue to be approved by FDA; 3) Medications and procedures to treat infertility, an area where MA offers unique strengths due to the large number of older mothers and high utilization of assisted reproductive technology (ART); 4) Medications that contain the endocrine-disruptor phthalates, which will be a model for proposing to study additional inactive ingredients in medications; 5) Antiepileptic medications including the study of genetic factors which increase the risk for birth defects; 6) Non- steroidal anti-inflammatory drugs, important because they are used by more than 20% of pregnant women; 7) Drugs for nausea and vomiting of pregnancy, key because of the increasing use of some medications for this pregnancy-specific condition; 8) Spatio-temporal clustering of birth defects, an indication of environmental or infectious etiology, including an expansion of our work on gastroschisis and extension of the research methodology to other birth defects; 9) Antidepressants, specifically selective serotonin reuptake inhibitors, including effect modifiers and genetically determined predictors related to specific agents; and 10) Medications taken during pregnancy, including over-the-counter products, and through a periodic screening of BD-STEPS data, identifying new products that may pose a risk. Through these activities, MCBDRP will be an essential partner in BD-STEPS to achieve our overall goal of translating research findings into meaningful prevention initiatives.