Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

加州大学欧文分校（UCI）具备参与该联盟评估未生育妇女早产的遗传和环境风险因素的必要条件。Deborah Wing （PI）和Pathik Wadhwa （co- 1）在研究设计、受试者招募、数据分析和来自nih资助和行业赞助的单点和多点研究的出版物方面拥有丰富的经验。Wing博士领导UCI妇产科，母胎医学部，并监督其奖学金和临床研究任务。Wadhwa博士是UCI行为围产期研究项目的主任，研究怀孕期间生物和行为过程之间的界面，指导美国国立卫生研究院（NIH）关于怀孕期间基因与环境相互作用的项目，并参加了大型工作组，概述早产遗传决定因素的研究需求。我们建议从UCI和我们在长滩纪念医疗中心的附属机构中招募具有丰富多样性的种族和民族混合的受试者。我们的临床企业和患者数量（每年7000例分娩）使我们为参与该联盟做好了充分的准备。我们的大多数病人在妊娠的前三个月接受产前护理。我们可以利用加州奥兰治县国家儿童研究先锋中心不断增长的研究基础设施来帮助招募，并可以将国家正常胎儿生长研究标准的基础设施带到这项新的研究中。这包括预先批准的调查管理方案、物理和超声检查、生物样本收集、超声医师培训和质量保证。我们有多个关于产前和产时数据的电子数据库。我们有一个专门的研究人员团队，还有一个由教职员工和我们的主要研究协调员组成的监督委员会，他们定期会面。我们最近聘请了陈东宝博士来监督我们的围产期研究实验室；他的小组可以提供与此RFA相关的专业知识。我们与新生儿科、遗传学、围产期病理学、临床实验室和研究药房建立了良好的合作关系，这有助于成功完成这项调查。UCI的独特之处在于其分子和线粒体医学与遗传学中心（MAMMAG），遗传流行病学研究所（GERI），基因组学和生物信息学研究所（IGB）以及太平洋-西南新兴疾病和生物恐怖主义中心（PSW RCE），每个中心都为早产的遗传和环境决定因素的研究提供了独特的优势。

The University of California, Irvine (UCI) has the required elements to participate in the consortium to evaluate genetic and environmental risk factors for preterm birth in nulliparous women. Deborah Wing (PI) and the Pathik Wadhwa (co-l) have extensive experience in study design, subject recruitment, data analysis, and publications from several NIH-funded and industry-sponsored single- and multiple-site studies. Dr. Wing directs the UCI Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine and oversees its fellowship and clinical research mission. Dr. Wadhwa, director of the UCI Behavioral Perinatology Research Program, examines the interface between biological and behavioral processes in pregnancy, directs an NIH program project on gene-environment interactions in pregnancy, and also has participated in large working groups to outline research needs for the genetic determinants of preterm birth. We propose recruitment of subjects from a richly diverse racial and ethnic mix from UCI and our affiliate at Long Beach Memorial Medical Center. Our clinical enterprise and patient population ("7000 deliveries/year) make us well-prepared to participate in this consortium. Most of our patients receive prenatal care in the first trimester. We can capitalize on the growing research infrastructure for the Orange County, California, Vanguard Center for the National Children's Study to aid in recruitment, and can bring to this new investigation the infrastructure of the National Standard for Normal Fetal Growth study. This includes pre-approved protocols for survey administration, physical and ultrasound exams, biosample collection, sonographer training, and quality assurance. We have multiple electronic databases in place for antepartum and intrapartum data. We have a dedicated team of research staff plus an oversight committee comprised of faculty members and our lead research coordinators who meet regularly. We recently recruited Dongbao Chen, PhD, to oversee our Perinatal Research Laboratory; his group can provide expertise relevant to this RFA. We have well-established collaborative ties with neonatology, genetics, perinatal pathology, clinical laboratory, and research pharmacies which can aid in successful completion of this investigation. Unique to UCI are its Center for Molecular and Mitochondrial Medicine and Genetics (MAMMAG), Genetic Epidemiology Research Institute (GERI), the Institute of Genomics and Bioinformatics (IGB), and the Pacific-Southwest Center for Emerging Diseases and Bioterrorism (PSW RCE), each of which lend particular strengths to the study of genetic and environmental determinants of preterm birth.