Data Coord. Center - NICHD Cooperative Multicenter Maternal Fetal Medicine Units

1986年，国家儿童健康和人类发展研究所创建了母胎医学单位（MFMU）网络，由一些主要的学术临床中心，数据协调中心和研究所本身组成。该网络的目的是进行临床研究，以减少不良妊娠和婴儿结局的风险，最终目标是促成一批进行良好的研究，作为围产期医学医疗决策的基础。目前，MFMU网络正在计划、开展和分析多项随机临床试验和观察性研究，涉及母胎医学的各个方面，如早产预防、先兆子痫的预测和预防、产科安全措施以及具有潜在风险因素（如亚临床甲状腺功能减退症）的孕妇的管理。乔治华盛顿大学生物统计中心提议继续担任该网络的数据协调中心。我们的目的是在研究设计、研究实施和统计分析方面提供专业知识和支持。我们将在每项研究的设计以及中期和最终分析的准备中提供统计领导。我们将准备研究文件，包括方案、操作手册和数据表，我们将继续提供全面的数据处理系统，包括分布式、网络和中央数据输入、数据库管理和数据质量控制。我们将协助研究者准备研究结果的手稿和摘要，并根据MFMU网络政策准备最终数据集以供共享。我们还将提供行政支持，例如安排提供研究药物和实验室检测的后勤服务、维护MFMU网络网站、协调会议、培训课程和结果审查。我们将有效和创造性地管理资源，以便我们能够及时开始新的研究。拟议的研究与公共卫生的相关性是明确和直接的。该网络的研究结果有可能使全世界的孕妇及其子女受益;例如，通过找到筛查怀孕问题的方法，通过找到改善儿童健康的产妇治疗方法，特别是通过找到有助于减轻早产婴儿问题的治疗方法。

DESCRIPTION (provided by applicant): In 1986, the National Institute of Child Health and Human Development created the Maternal-Fetal Medicine Units (MFMU) Network, consisting of a number of major academic clinical centers, a data coordinating center, and the Institute itself. The purpose of the Network was to conduct clinical research aimed at reducing the risk of adverse pregnancy and infant outcome with the ultimate goal of contributing a body of well-conducted studies on which to base medical decisions in perinatal medicine. At present, the MFMU Network is planning, conducting and analyzing multiple randomized clinical trials and observational studies in various aspects of maternal-fetal medicine such as preterm birth prevention, prediction and prevention of preeclampsia, measures of obstetrical safety and the management of pregnant women with potential risk factors such as subclinical hypothyroidism. The George Washington University Biostatistics Center proposes to continue to serve as the data coordinating center for the Network. Our purpose is to provide expertise and support in study design, study conduct and statistical analysis. We will provide statistical leadership in the design of each research study and in the preparation of interim and final analyses. We will prepare study documents, including protocols, manuals of operations and data forms, and we will continue to provide a comprehensive data processing system including distributed, web and central data entry, data base management and data quality control. We will assist investigators in the preparation of manuscripts and abstracts from study results and we will prepare the final dataset for sharing per MFMU Network policy. We will also provide administrative support such as arrangement of logistical services for provision of study drugs and laboratory assays, maintenance of the MFMU Network website, coordination of meetings, training sessions and outcome reviews. We will manage resources effectively and creatively, so that we can start new studies in a timely manner. The relevance of the proposed research to public health is clear and direct. The results of the Network studies potentially can benefit pregnant women and their children worldwide; for example, by finding methods to screen for problems in pregnancy, by finding maternal treatments that improve children's health, and especially by finding treatments that can help lessen the problem of babies being born too early.