NICHD Maternal Fetal Medicine Units Network

 描述(由申请者提供)：宾夕法尼亚大学妇产科反映了在临床和翻译研究方面优秀的悠久传统。母胎医学部(MFM)及其母婴健康研究方案(MCHRP)是这一传统的主要参与者。在这份申请中，提供了关于在宾夕法尼亚大学卫生系统(Penn)的两家医院-宾夕法尼亚大学医院(HUP)和宾夕法尼亚医院(PAH)-进行临床研究的产科服务和经过证明的跟踪记录的信息，这两家医院是为这一母婴医学单元(MFMU)网络应用程序建议招募患者的地点。每年约有9000名妇女在宾夕法尼亚大学分娩，其中许多妇女被记录为高危怀孕。宾夕法尼亚大学的产科人口也有不同的种族和民族背景，这将是注册MFMU研究的重要资产。在宾夕法尼亚大学拟议的MFMU站点将在非常成功的MCHRP范围内运作，该站点提供持续的产前和产中研究登记(24/7)，在HUP和PAH的所有主要临床站点招募门诊患者，并建立生物标本收集和数据库管理方案。MCHRP协调员与宾夕法尼亚大学新生儿研究网络的协调员密切合作，提供新生儿随访。MCHRP对于成功招募1,100名妇女参加宾夕法尼亚大学nuMoM2B网络研究(U01-HD05088)至关重要，MCHRP是最近指定的宾夕法尼亚大学迪梅斯早产研究中心3月的关键资产。为宾夕法尼亚大学的MFMU地点拟议的调查小组具有指导多中心研究的丰富经验，每个调查员都有令人兴奋的研究议程，这将为MFMU网络增加独特的视角。研究人员在早产、胎盘生物学、基因组学、蛋白质组学和代谢组学、阴道和肠道微生物组、孕妇遗传疾病筛查以及产科护理模式等方面都有可靠的记录。拟议的调查人员认识到这项申请的几个关键的具体目标：1)帮助确定围产期医学研究的最高优先级问题；2)在MFMU网络的协作环境中工作，以设计和实施解决高优先级问题的研究项目；3)为MFMU研究提供最高质量的数据，并及时提供这些数据；以及4)参与MFMU网络进行的研究的分析和发布。宾夕法尼亚大学妇产科的研究环境令人兴奋，并在不断增长，拟议的领导团队反映了该部门对MFMU网络的全面参与的坚定承诺。调查人员将能够利用现有计划的基础设施，在宾夕法尼亚开发一个成功的MFMU地点，达到和/或超过本申请中提出的四个具体目标的所有目标。

 DESCRIPTION (provided by applicant): The University of Pennsylvania's Department of Obstetrics and Gynecology reflects a long tradition of excellence in clinical and translational research. The Division of Maternal-Fetal Medicine (MFM) and its Maternal and Child Health Research Program (MCHRP) have been key participants in this tradition. In this application, information is provided on the obstetrical service and the proven track record for conducting clinical research at the two hospitals in the University of Pennsylvania Health System (Penn) - the Hospital of the University of Pennsylvania (HUP) and Pennsylvania Hospital (PAH) - which are proposed sites of patient recruitment for this Maternal-Fetal Medicine Units (MFMU) Network application. Each year, approximately 9,000 women are delivered at Penn, and many of these women are documented to be high-risk pregnancies. The obstetric population at Penn also has a diverse racial and ethnic background, which will be an important asset for enrollment in MFMU studies. The proposed MFMU site at Penn will operate within the highly successful MCHRP, which offers continuous enrollment (24/7) into antepartum and intrapartum research studies, outpatient recruitment at all major clinical sites at HUP and PAH, and established protocols for biospecimen collection and databanking. The MCHRP coordinators work closely with coordinators from the Neonatal Research Network at Penn to provide neonatal follow-up. The MCHRP was critical for the successful enrollment of 1,100 women into the nuMoM2b Network study at Penn (U01-HD05088), and the MCHRP is a key asset for the recently designated March of Dimes Center for Prematurity Research at Penn. The investigative team proposed for the MFMU site at Penn has significant experience directing multicenter studies, and each investigator has an exciting research agenda that will add unique perspectives to the MFMU Network. The investigators have a proven track record studying preterm birth; placental biology; genomics, proteomics, and metabolomics; vaginal and gut microbiome; maternal screening for genetic disorders; and models of obstetrical care. The proposed investigators recognize several key specific aims of this application: 1) To aid in the identification of the highest priority issues for research in perinatal medicine; 2) To work within the collaborative environment of the MFMU Network toward the design and implementation of research projects that address high priority issues; 3) To provide the highest quality data for MFMU studies and to provide these data in a timely fashion; and 4) To be involved in the analysis and publication of studies performed by the MFMU Network. The research environment in the Department of Obstetrics and Gynecology at Penn is exciting and continually growing, and the proposed leadership team reflects a strong commitment for full engagement by the department in the MFMU Network. The investigators will be able to leverage the infrastructure of existing programs to develop a successful MFMU site at Penn that meets and/or exceeds all objectives of the four specific aims proposed in this application.