Cooperative Multicenter Maternal Fetal Medicine Units Networks

描述（由申请人提供）：在过去的九年中，作为MFMU网络的成员，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个网站中的招聘排名第四，在坚持性和整体质量方面排名第三。我们在西班牙裔招聘方面表现出色;我们的参与者中有31%是西班牙裔。作为一个强大的网站，再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网络的高产成员。我们在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且忠诚的团队，该研究人员联盟致力于通过最先进的研究了解和改善妊娠结局。该核心得到了完善的基础设施的支持，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级的综合临床研究中心之一。该组织作为牵头组织，另外两个医疗保健机构（Wake AhecA/WakeMed和雷克斯医院）作为招聘网站。随着第三个招募地点的增加，即本申请中的MAHEC/使命医院，我们每年有超过19，000例分娩，其中33%因母体合并症而具有高风险，包括药物滥用，胎儿畸形，妊娠并发症或早产风险特征，包括多胎妊娠。卫生部和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/使命医院为该州西部的17个县提供同样的服务。总的来说，WakeMed和Mission医院的大多数产前病人都很贫穷;雷克斯医院的病人主要是风险较低的病人，大多数人都有某种形式的私人保险; MAHEC/使命医院的病人大约各占一半。我们招募的种族和民族多样性很强，64%的白色参与者和27%的非洲裔美国人;另外31%是西班牙裔。Wake AHEC/WakeMed和MAHEC/使命拥有最先进的三级新生儿重症监护室，雷克斯拥有二级托儿所。总之，这四个组成部分的医疗保健系统带来了超过二十年的生产多站点研究，经验丰富的调查人员，国家的最先进的护理设施，稳定的人口，不断增强的计算机化围产期数据库，并致力于卓越的合作研究的一部分MFMU。 公共卫生相关性：北卡罗来纳州大学的产妇胎儿医学单位（MFMU）网络网站在过去的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月开始了另外两项试验。网络研究调查临床产科的问题，特别是与低出生体重，早产和妊娠的医疗问题有关的问题，并有助于母胎医学领域循证实践的发展。这在北卡罗来纳州尤为重要，因为该州在围产期/孕产妇健康和婴儿死亡率方面排名全国倒数第三。

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.