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

描述(由申请人提供)：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，最终目的是促成一系列进行良好的研究，作为围产期医学决定的基础。目前，MFMU网络正在规划、进行和分析母胎医学各个方面的多项随机临床试验和观察性研究，如早产预防、预测和预防先兆子痫、产科安全措施以及对亚临床甲状腺功能减退等潜在风险因素的孕妇的管理。乔治华盛顿大学生物统计中心建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。我们将在每项研究研究的设计以及中期和最终分析的准备方面提供统计领导。我们将编写研究文件，包括协议、操作手册和数据表格，并将继续提供一个全面的数据处理系统，包括分布式、网络和中央数据录入、数据库管理和数据质量控制。我们将协助研究人员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助，例如为提供研究药物和实验室化验安排后勤服务，维护MFMU网络网站，协调会议、培训课程和结果审查。我们将有效地、创造性地管理资源，以便及时开展新的研究。拟议的研究与公共卫生的相关性是明确和直接的。该网络的研究结果可能使世界各地的孕妇及其子女受益；例如，通过寻找方法来筛查怀孕期间的问题，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婴儿过早出生问题的治疗方法。

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.