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

描述（由申请人提供）：本提案旨在描述西北研究中心的组织结构、提供者参与、研究受试者招募和保留策略、方案实施程序和科学能力，以满足研究的总体目标：“未经产妇女的早产：研究不足的人群风险很大。“这项对未生育妇女的观察性研究的最终目的是：（即环境、遗传、生理）与早产相关;以识别胎盘特征（即发育和功能）与早产相关;以确定胎儿特征（即遗传，生长，发育）与早产相关;并使用这些特征来更好地预测早产并了解其背后的机制。相应地，西北研究中心将：1.提供有效的组织结构和管理方法，以支持“未产妇早产”研究的目标; 2.利用和扩大西北研究中心的现有关系，制定和实施有效的策略，招募未经产的产妇，并在整个研究过程中保留这些受试者; 3.建立和实施符合“未产妇早产”研究要求的调查数据、超声检查、体格检查和标本采集流程; 4.促进临床中心之间的科学合作，以支持研究目标，并充分和创新地利用“未经产妇女早产”研究的独特数据。 公共卫生相关性：未生育妇女在不良妊娠结果中所占比例过高，特别是早产，造成了巨大的健康和经济负担。拟议的研究网络和研究有可能提高我们对早产病因和预测的认识，并将有助于指导有针对性的预防和治疗策略的制定。

DESCRIPTION (provided by applicant): This proposal seeks to describe this organizational structure, provider engagement, study subject recruitment and retention strategies, protocol implementation procedures, and scientific capabilities of the Northwestern Study Center to meet the overall objectives of the investigation: "Preterm birth in nulliparous women: an understudied population at great risk." The ultimate aims of this observational study of nulliparous women are: to identify maternal characteristics (i.e. environmental, genetic, physiologic) that are associated with preterm delivery; to identify placental characteristics (i.e. developmental and functional) that are associated with preterm delivery; to identify fetal characteristics (i.e. genetic, growth, developmental) that are associated with preterm delivery; and to use these characteristics to better predict preterm delivery and understand the mechanisms that underlie it. Correspondingly, the Northwestern Study Center will: 1. Provide an effective organizational structure and management approach to support the objectives of the "Preterm birth in nulliparous women" study; 2. Utilize and expand upon the existing relationships of the Northwestern Study Center to develop and implement effective strategies for the recruitment of nulliparous parturients and the retention of these subjects throughout the study; 3. Establish and implement survey data, ultrasound examination, physical examination, and specimen collection processes that meet the requirements of the "Preterm birth in nulliparous women" study; and 4. Contribute to the scientific collaboration among the clinical centers to support the study's objectives and make full and innovative use of the unique data resulting from the "Preterm birth in nulliparous women" study. PUBLIC HEALTH RELEVANCE: Nulliparous women account for a disproportionate share of adverse pregnancy outcomes, and in particular of preterm births, which are responsible for a signficant health and financial burden. The proposed research network and study has the potential to enhance our undertanding of the etiologies and prediction of preterm birth, and therein will help to guide the development of targeted prevention and therapeutic strategies.