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: 10421034
• 负责人: ALLEN A MITCHELL
• 金额: $ 105万
• 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/10421034
• 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.

项目摘要 /摘要 马萨诸塞州（MA）出生缺陷研究与预防中心（MCBDRP）提议继续 它进行病因学研究以确定结构性出生的可修改风险因素的良好记录 缺陷通过参与先天缺陷研究来评估妊娠暴露II（BD-Steps II）。 我们将通过利用与当地大学的长期关系来提高我们的贡献 未来的出生缺陷研究人员。 MCBDRP带来了BD-Steps II我们在我们的专业知识和领导 药物ePidemiology和合作利用独特的数据资源将应用于所有三个关键 在资助机会通知中命名的感兴趣领域。我们的研究将利用现有数据 国家出生缺陷预防研究，BD步骤I和将作为BD-Steps II的一部分收集的数据。这 MCBDRP调查人员致力于成功的导师和合作伙伴，角色将 继续并在BD-Steps II内进行扩展。在五年的赠款期内，MCBDRP至少将完成 10个具有公共卫生意义的病因研究项目，将有助于咨询妇女考虑 导致出生缺陷的可能性较小的暴露；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，这是防止母亲传播的关键，但在 他们在出生缺陷方面的安全； 3）评估过去并且将会的抗肥胖药物 继续获得FDA的批准，并评估越来越多执行的减肥手术程序； 4）调查注意力缺陷多动障碍药物，其使用增加了 急剧5）衡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）探索妊娠药物使用趋势以识别正在变得相对越来越多的药物 通常用于怀孕； 7）利用州实验室的可报告疾病数据库探讨 怀孕前后的感染出生缺陷； 8）考虑叶酸途径 支持单碳代谢途径的因素及其在神经管发育中的作用； 9） 探索伴有羊膜带和末端横向肢体的肢体减少缺陷 缺陷以了解它们是否具有共同的风险因素和发病机理； 10）利用这一独特 评估新引入药物怀孕的相对风险/安全性的数据源，这是必不可少的 鉴于没有正在进行的系统性方法来监测美国妊娠的药物安全。为我们 药物验证试验研究我们将考虑从初始处方得出的处方药 （病历），药房分配（索赔数据）和孕产妇使用报告（前瞻性收集的数据 在移动应用程序中）。通过这些活动，MCBDRP将成为BD-Steps II的重要合作伙伴 实现我们将研究发现转化为预防先天缺陷的有意义举措的总体目标。

项目成果

Factors associated with infant sex and preterm birth status for selected birth defects from the National Birth Defects Prevention Study, 1997-2011.

1997-2011 年国家出生缺陷预防研究中与婴儿性别和特定出生缺陷早产状况相关的因素。

• DOI: 10.1002/bdr2.2294
• 发表时间: 2024
• 期刊: Birth defects research
• 影响因子: 2.1
• 作者: Williford,EvaM;Yang,Wei;Howley,MeredithM;Ma,Chen;Collins,RonnieT;Weber,KariA;Heinke,Dominique;Petersen,JulieM;Agopian,AJ;Archer,NatalieP;Olshan,AndrewF;Williams,LindsayA;Browne,MarilynL;Shaw,GaryM;NationalBirthDefe
• 通讯作者: NationalBirthDefe

Periconceptional maternal fever, folic acid intake, and the risk for neural tube defects.

• DOI: 10.1016/j.annepidem.2017.10.010
• 发表时间: 2017-12
• 期刊: Annals of epidemiology
• 影响因子: 5.6
• 作者: Kerr SM;Parker SE;Mitchell AA;Tinker SC;Werler MM
• 通讯作者: Werler MM

Vasoactive exposures and risk of amniotic band syndrome and terminal transverse limb deficiencies.

• DOI: 10.1002/bdr2.1740
• 发表时间: 2020-08
• 期刊: BIRTH DEFECTS RESEARCH
• 影响因子: 2.1
• 作者: Adrien, Nedghie;Petersen, Julie M.;Parker, Samantha E.;Werler, Martha M.
• 通讯作者: Werler, Martha M.

Use of vasoactive medications in pregnancy and the risk of stillbirth among birth defect cases.

• DOI: 10.1002/bdr2.1996
• 发表时间: 2022-05
• 期刊: BIRTH DEFECTS RESEARCH
• 影响因子: 2.1
• 作者: Kerr, Stephen;Heinke, Dominique;Yazdy, Mahsa M.;Mitchell, Allen A.;Darling, Anne Marie;Lin, Angela;Nestoridi, Eirini;Werler, Martha M.
• 通讯作者: Werler, Martha M.

An application of data mining to identify potential risk factors for anophthalmia and microphthalmia.

应用数据挖掘来识别无眼症和小眼症的潜在危险因素。

• DOI: 10.1111/ppe.12509
• 发表时间: 2018
• 期刊: Paediatric and perinatal epidemiology
• 影响因子: 2.8
• 作者: Weber,KariA;Yang,Wei;Carmichael,SuzanL;Lupo,PhilipJ;Dukhovny,Stephanie;Yazdy,MahsaM;Lin,AngelaE;VanBennekom,CarlaM;Mitchell,AllenA;Shaw,GaryM;NationalBirthDefectsPreventionStudy
• 通讯作者: NationalBirthDefectsPreventionStudy