Cooperative Multicenter Maternal Fetal Medicine Units Networks

描述(申请人提供)：在过去的九年里，作为MFMU网络的成员，北卡罗来纳大学MFMU网站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。我们在14个网站的招聘人数中排名第四，在忠诚度和总体质量方面排名第三。北卡罗来纳大学在西班牙裔招聘方面表现出色；总体来说，我们的参与者中有31%是西班牙裔。作为一个强大的网站，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，我们非常适合继续作为该网络的高生产率成员。我们在我们的围产期研究核心中组建了一支由医生、研究员、研究生、研究护士、临床研究助理、实验室工作人员和其他研究人员组成的才华横溢、尽职尽责的团队，这是一个致力于通过最先进的研究了解和改善妊娠结局的研究联盟。核心由完善的基础设施支持，包括临床跟踪系统、数据管理资源、NIH临床营养研究中心和全国顶尖的综合临床研究中心之一。北卡罗来纳大学是牵头组织，另外两个北卡罗来纳大学医疗保健地点(Wake Aheca/WakeMed和Rex医院)作为招聘地点。在这项应用中增加了第三个招募地点，MAHEC/使命医院，我们每年有超过19,000名新生儿在各个地点出生，其中33%是由于母亲并存的高风险，包括药物滥用、胎儿异常、妊娠并发症或早产风险特征，包括多胎妊娠。北卡罗来纳大学和WakeMed几乎为该地区提供了所有高危产前诊所和基于医院的护理，MAHEC/使命医院为该州西部的17个县提供了同样的服务。总体而言，WakeMed和UNC的大多数产前患者都很贫穷；REX患者主要是低风险患者，大多数人有某种形式的私人保险；MAHEC/使命医院的患者大约各占一半。在我们的招募中，种族和民族的多样性一直很强，的参与者中有27%是白人，27%是非裔美国人，另外31%是西班牙裔。北卡罗来纳大学、Wake AHEC/WakeMed和MAHEC/使命拥有最先进的III级新生儿重症监护病房，Rex拥有II级托儿所。作为MFMU的一部分，北卡罗来纳大学医疗保健系统的这四个组成部分共同带来了20多年的多站点研究成果、经验丰富的研究人员、最先进的护理设施、稳定的人口、不断增强的计算机化围产期数据库以及致力于卓越的合作研究。 公共卫生相关性：北卡罗来纳大学母胎医学部(MFMU)网站在过去九年里一直是该网络的重要贡献者，完成了八项随机临床试验，有两项观察性研究和两项随机试验正在进行中，并在6月份开始了另外两项试验。网络研究调查产科临床问题，特别是与低出生体重、早产和妊娠医学问题有关的问题，并有助于母婴医学领域循证实践的发展。这在北卡罗来纳州尤其重要，因为该州在围产期/产妇健康和婴儿死亡率方面排名全国倒数三分之一。

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.