NICHD Maternal-Fetal Medicine Units (MFMU) Network

 描述(由申请人提供)：本提案的目的是总结匹兹堡大学医学中心(UPMC)玛吉妇女医院(UPMC)的资源，并展示我们将如何为NICHD赞助的母婴医学单位网络的使命和目标做出有意义的贡献。我们的单位积极参与了三项单中心和多中心观察性和干预性临床研究 几十年，包括nuMoM2B网络和产科-胎儿药理学研究网络，以及MFMU网络的前几次迭代。我们的记录表明，我们愿意与其他机构和NICHD在制定和实施临床研究方案方面进行合作。我们一直是多中心网络各个方面的积极参与者。我们曾提出方案，曾在其他方案的小组委员会任职，曾在行政小组委员会任职，并曾作为网站访问者对其他中心进行评估。我们已经有效地招募了患者，并在开发新项目以及执行我们中心和其他人的方案方面提供了智力投入。匹兹堡大学的产科是美国最大的私立学术产科服务机构之一，每年有超过1万例分娩。我们大约40%的患者被认为是临产前的高危人群。本申请表中详细介绍了我们的人口统计数据以及我们的高入学率，这有助于确保Network Study的结果广泛适用于各种不同的科目。在这份提案中，我们将：(1)描述我们参与不良妊娠结局单中心和多中心研究的经验、基础设施和跟踪记录；(2)展示我们有能力招募参加MFMU试验的受试者并为其提供孕产妇和新生儿随访；以及(3)描述我们在技术和多学科内容专业知识方面的独特适用性，以实现MFMU网络的目标。我们热衷于为MFMU网络的成功及其在临床研究中的持续领先地位做出贡献

 DESCRIPTION (provided by applicant): The purpose of this proposal is to summarize the resources at Magee Womens Hospital of the University of Pittsburgh Medical Center (UPMC) and to demonstrate how we will contribute meaningfully to the mission and objectives of the NICHD-sponsored Maternal- Fetal Medicine Units Network. Our Unit has been an active participant in single- and multi-center observational and interventional clinical studies for three decades, including the NuMom2b network, and the Obstetric-Fetal Pharmacology Research network, and previous iterations of the MFMU Network. Our track record establishes that we have demonstrated our willingness to cooperate with other institutions and the NICHD in the development and implementation of clinical research protocols. We have been active participants in every aspect of multicenter networks. We have proposed protocols, have served on subcommittees of other protocols, have served on administrative subcommittees, and have served as site visitors to evaluate other centers. We have effectively recruited patients and have provided intellectual input in the development of new projects as well as the implementation of protocols from our center and from others. The obstetrical unit at the University of Pittsburgh is one of the largest private academic obstetrical services in the United States with over 10,000 deliveries annually. Approximately 40% of our patients are deemed to be high risk prior to labor. The demography of our population, detailed in this application, and our high enrollment rates help ensure that results of Network studies are widely applicable across a diverse spectrum of subjects. In this proposal we will: (1) describe our experience, infrastructure, and track record o participation in single-center and multicenter studies of adverse pregnancy outcome; (2) demonstrate our ability to enroll and provide maternal and newborn follow-up to subjects enrolled in MFMU trials; and (3) delineate our unique suitability in terms of technical and multidisciplinary content expertise to address the objectives of the MFMU Network. We are enthusiastic about contributing to the success of the MFMU Network and its continued pre-eminence in clinical research