NICHD Maternal Fetal Medicine Units Network

 描述（由申请人提供）：宾夕法尼亚大学妇产科系反映了在临床和转化研究方面的悠久传统。母胎医学部（MFM）及其妇幼保健研究计划（MCHRP）一直是这一传统的主要参与者。在本申请中，提供了有关产科服务的信息以及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））开展临床研究的可靠记录，这两家医院是本母胎医学单位（MFMU）网络申请的患者招募地点。每年，大约有9,000名妇女在宾夕法尼亚州分娩，其中许多妇女被记录为高危妊娠。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MFMU研究入学的重要资产。宾夕法尼亚州拟议的MFMU研究中心将在非常成功的MCHRP中运作，该研究中心提供产前和产时研究的连续入组（24/7），HUP和PAH所有主要临床研究中心的门诊招募，以及生物标本采集和数据库的既定方案。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名女性进入宾夕法尼亚大学的nuMoM 2b网络研究（U 01-HD 05088）至关重要，MCHRP是最近指定的宾夕法尼亚大学March of Dimes早产儿研究中心的关键资产。为宾夕法尼亚大学MFMU研究中心提议的研究团队具有指导多中心研究的丰富经验，每位研究人员都有一个令人兴奋的研究议程，这将为MFMU网络增添独特的视角。研究人员在研究早产、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、遗传疾病的母体筛查以及产科护理模式方面有着良好的记录。拟议的研究人员认识到本申请的几个关键具体目标：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; 4）参与MFMU网络进行的研究的分析和出版。在宾夕法尼亚大学妇产科系的研究环境是令人兴奋的，并不断增长，拟议的领导团队反映了由该部门在MFMU网络充分参与的坚定承诺。研究人员将能够利用现有项目的基础设施，在宾夕法尼亚州开发一个成功的MFMU网站，满足和/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.