Cooperative Multicenter Maternal Fetal Medicine Units Networks

描述（由申请人提供）：在过去的九年里，作为MFMU网络的成员，UNC MFMU站点已经完成了六项随机临床试验，并有一项观察性研究和两项网络试验正在进行中。在14家商学院中，我们在招聘方面排名第四，在学员坚持度和总体质量方面排名第三。UNC擅长西班牙裔招聘；总的来说，31%的参与者是西班牙裔。作为一个强大的站点，加上我们在临床试验研究和围产期流行病学方面的卓越传统，使我们非常适合继续作为该网络的高效成员。我们组建了一支由医生、研究员、研究生、研究护士、临床研究助理、实验室工作人员和围产期研究核心的其他研究人员组成的有才华和忠诚的团队，这是一个致力于通过最先进的研究来理解和改善妊娠结局的研究人员联盟。核心是由一个完善的基础设施，包括临床跟踪系统，数据管理资源，美国国立卫生研究院临床营养研究中心，并在全国顶级的一般临床研究中心之一的支持。UNC作为主要组织，另外两个UNC医疗保健地点（Wake ahea /WakeMed和Rex医院）作为招聘地点。加上第三个招募地点，MAHEC/教会医院，我们每年在各个地点有超过19,000名新生儿，其中33%的新生儿由于产妇合共病而处于高风险，包括药物滥用、胎儿异常、妊娠并发症或早产风险，包括多胎妊娠。UNC和WakeMed为该地区提供几乎所有的高风险产前诊所和医院护理，MAHEC/教会医院为该州西部的17个县提供同样的服务。总体而言，WakeMed和UNC的大多数产前患者都很贫困；Rex的患者主要是低风险患者，大多数人都有某种形式的私人保险；MAHEC/教会医院的病人大约是一半一半。在我们的招聘中，种族和民族多样性很强，白人参与者占64%，非裔美国人占27%；另外31%是西班牙裔。UNC、Wake AHEC/WakeMed和MAHEC/Mission拥有最先进的三级新生儿重症监护病房，Rex拥有二级托儿所。总之，北卡罗来纳大学医疗保健系统的这四个组成部分带来了二十多年来富有成效的多站点研究，经验丰富的研究人员，最先进的护理设施，稳定的人口，不断增强的计算机围产期数据库，以及作为MFMU一部分的卓越合作研究的承诺。

DESCRIPTION (provided by applicant): Over the past nine years as a member of the MFMU network, the UNC MFMU site has completed six randomized clinical trials and has one observational study and two network trials ongoing. We are number four in recruiting among the 14 sites, and are ranked number three in adherence and quality overall. UNC excels at Hispanic recruitment; overall 31% of our participants are Hispanic. This track record as a strong site, coupled with our tradition of excellence in clinical trials research and perinatal epidemiology makes us ideally suited to continue as a highly productive member of the Network. We have assembled a talented and committed team of physicians, fellows, graduate students, research nurses, clinical research assistants, laboratory staff, and other investigators in our Perinatal Research Core, an alliance of investigators dedicated to understanding and improving pregnancy outcomes through state-of-the-art research. The Core is supported by a well-established infrastructure consisting of clinical tracking systems, data management resources, an NIH Clinical Nutrition Research Center, and one of the top General Clinical Research Centers in the nation. UNC serves as the lead organization with two other UNC Healthcare locations (Wake AhecA/WakeMed and Rex Hospital) serving as recruitment sites. With the addition of a third recruitment site, MAHEC/Mission Hospital in this application, we have more than 19,000 births each year across sites, 33% of which are high-risk by virtue of maternal co-morbidities, including substance abuse, fetal anomalies, pregnancy complications, or preterm birth risk profile, including multiple gestations. UNC and WakeMed provide virtually all of the high-risk prenatal clinic and hospital-based care for this region, and MAHEC/Mission Hospital provides the same for 17 counties in the western part of the state. Overall, the majority of prenatal patients at WakeMed and UNC are indigent; the Rex patient population is predominately lower risk patients and the majority has some form of private coverage; MAHEC/Mission Hospital patients are roughly half and half. Racial and ethnic diversity in our recruitment has been strong with 64% white participants and 27% African Americans; additionally 31% are Hispanic. UNC, Wake AHEC/WakeMed, and MAHEC/Mission have state of the art Level III neonatal intensive care units, and Rex has a Level II nursery. Together, these four components of the UNC Healthcare System bring more than twenty years of productive multi-site research, experienced investigators, state-of-the-art care facilities, a stable population, ongoing enhancements of computerized perinatal databases, and commitment to excellence in collaborative research as part of the MFMU. PUBLIC HEALTH RELEVANCE: The University of North Carolina Maternal Fetal Medicine Unit (MFMU) network site has been a significant contributor to the network for the past nine years, completing eight randomized clinical trials, having two observational studies and two randomized trials in progress, and starting two more trials in June. Network studies investigate problems in clinical obstetrics, particularly those related to low birth weight, prematurity, and medical problems of pregnancy, and contribute to the development of evidence-based practices in the field of maternal-fetal medicine. This is particularly important in North Carolina as the state ranks in the bottom third of the nation with regard to perinatal/maternal health and infant mortality.