Oral Corticosteroid Use During Pregnancy and Risk for Preterm Birth

怀孕期间口服皮质类固醇的使用和早产风险

基本信息

批准号：
9754218
负责人：
Kristin Palmsten
金额：
$ 23.09万
依托单位：
HEALTHPARTNERS INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-01 至 2021-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9754218
关键词：
37 weeks gestation Accounting Address Adrenal Cortex Hormones Alternative Therapies Applications Grants Area Asthma Attenuated Autoimmune Diseases Award Biostatistical Methods Birth California Childhood Clinical Pharmacology Complex Data Data Set Data Sources Disease-Modifying Second-Line Drugs Documentation Dose Education Environment Epidemiology Faculty Foundations Funding Goals Grant Health Health Personnel Health Professional Health Services Histologic Human Immunosuppression Inhalation Instruction K-Series Research Career Programs Knowledge Literature Measures Mediation Medicaid Medical Records Mentored Clinical Scientist Development Award (K08)Mentors Methodological Studies Methodology Modeling Modification Mothers Oral Outcome Pathology Pathway interactions Perinatal Pharmaceutical Preparations Pharmacists Pharmacology Phase Physicians Placenta Positioning Attribute Practice based research Pregnancy Pregnant Women Premature Birth Prospective cohort Proxy Public Health Publishing Reporting Research Research Personnel Risk Safety Severity of illness Teratology Universities Vasculitis Woman Writing alternative treatment base career career development clinical Diagnosis clinical application clinical decision-making clinically relevant cohort comparative experience fetal health care service utilization health practice improved infant morbidity/mortality infection risk innovation intraamniotic infection intrauterine infection medication safety member pediatric department perinatal outcomes programs prospective public health relevance research and development skills treatment risk

项目摘要

DESCRIPTION (provided by applicant): I am a postdoctoral scholar in the Department of Pediatrics at the University of California, San Diego (UCSD), and I am applying for the K99/R00 Pathway to Independence Award to facilitate my transition to become an independent investigator of medication safety during pregnancy. My background is in epidemiology and my career goal is to conduct research regarding the risks of medication use during pregnancy on perinatal and pediatric health to inform the complex treatment decisions that women and their health care providers must make. To develop my capacity to become an independent investigator, I am proposing an intensive career development and research program. Specifically, I propose (1) to increase my knowledge of pharmacology concepts, drug information, and human teratology, (2) to gain additional experience conducting studies using prospective cohort and healthcare utilization data and disseminating findings to healthcare professionals, and (3) to strengthen my grant writing skills. I have assembled the ideal team of 5 UCSD faculty members to provide me with guidance and instruction in these areas. My primary mentor, Dr. Christina Chambers, is a leader in the field of medication safety during pregnancy. My co-mentors are: Dr. Brookie Best, an expert in clinical pharmacology during pregnancy; Dr. Grace Kuo who has expertise in health services and practice-based research; Dr. Todd Gilmer, an expert in conducting research with Medicaid data; and Dr. Ronghui Xu, who has expertise in applying biostatistics methods to studies of medication in pregnancy. The objective of the proposed research is to inform clinical decision making regarding oral corticosteroid use versus alternative treatments for asthma and autoimmune diseases during pregnancy. I am proposing to assess the association between oral corticosteroid use during pregnancy and risk for preterm birth among pregnant women with asthma and autoimmune diseases. I will compare oral corticosteroids with alternative treatments (e.g., inhaled corticosteroids and disease modifying antirheumatic drugs) and no treatment. I will use both prospectively collected cohort data and healthcare utilization data to conduct the study, and I will compare and contrast these methodological approaches. Furthermore, I will disseminate the results, within the context of previous research, to clinicians. The proposed study is responsive to the urgent public health need for information regarding the impact of oral corticosteroid use on risk for preterm birth. I will develop expertise in working with cohort and healthcare utilization data, and will gain experience comparing study methodologies and developing clinical applications related to medication safety research. Building on this innovative research, I will develop a competitive R01 grant proposal to pursue studying commonly used medications during pregnancy that have inadequate human safety data.

描述（由应用程序提供）：我是加利福尼亚大学圣地亚哥分校（UCSD）儿科科的博士后科学，我正在申请K99/R00独立奖，以支持我的过渡，以成为怀孕期间的独立药物调查员。我的背景是流行病学，我的职业目标是对怀孕期间对围产期和小儿健康的药物使用风险进行研究，以告知妇女及其卫生保健提供者必须做出的复杂治疗决定。为了发展我成为独立研究者的能力，我提出了一个密集的职业发展和研究计划。具体而言，我建议（1）提高我对药理学概念，药物信息和人类术语的了解，（2）以使用前瞻性队列和医疗保健利用数据来获得额外的经验进行研究，并将发现向医疗保健专业人员传播，以及（3）以增强我的赠款写作能力。我已经组建了5位UCSD教职员工的理想团队，为我提供了这些领域的指导和指导。我的主要导师克里斯蒂娜·钱伯斯（Christina Chambers）博士是怀孕期间药物安全领域的领导者。我的联合官员是：Brookie Best博士，怀孕期间临床药理学专家；格蕾丝·库（Grace Kuo）博士在卫生服务和实践研究方面具有专业知识；托德·吉尔默（Todd Gilmer）博士，通过医疗补助数据进行研究专家； Ronghui Xu博士，他在怀孕中使用生物统计学方法的专家。拟议的研究的目的是为怀孕期间的哮喘和自身免疫性疾病提供有关口服皮质类固醇使用与替代治疗的临床决策。我建议评估怀孕期间口服皮质类固醇的相关性与哮喘和自身免疫性疾病孕妇的早产风险。我将将口服皮质类固醇与替代治疗（例如，吸入的皮质类固醇和疾病修饰抗炎性药物）进行比较，没有治疗。我将使用前瞻性收集的队列数据和医疗保健利用数据进行研究，并将比较和对比这些方法论方法。此外，我将在先前研究的背景下将结果传播给临床医生。拟议的研究旨在应对紧急的公共卫生需求，以了解有关口服皮质类固醇对早产风险的影响的信息。我将开发与队列和医疗保健利用数据合作的专家，并将获得比较研究方法和开发与药物安全研究相关的临床应用的经验。在这项创新研究的基础上，我将开发一项有竞争力的R01赠款提案，以在怀孕期间进行研究，而人类安全数据不足。