NICHD Maternal Fetal Medicine Units Network

描述（由申请人提供）：作为网络的新成员，UNC MFMU站点已完成4项随机临床试验和1项观察性研究；正在进行两项试验的后续研究；目前正在进行五项试验。在所有网络网站中，我们的总招聘人数一直排在上半部分，在西班牙裔招聘方面表现出色。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了解和改善妊娠结局的研究人员联盟。核心中心得到了完善的基础设施的支持，包括临床跟踪系统、数据管理资源和专业研究服务，如计算机辅助电话访谈设施、美国国立卫生研究院临床营养研究中心（全国顶级综合临床研究中心之一）、炎症性疾病综合中心、口腔和全身疾病中心以及妇女健康研究中心。在这个应用程序中增加了Rex Healthcare，我们的网站每年有超过13,000个新生儿，其中33%是高风险的，因为孕产妇共病，包括药物滥用，胎儿异常，妊娠并发症，或早产风险档案，包括多胎妊娠。UNC和WakeMed为我们的产前人群提供几乎所有的高风险产前诊所和医院护理，因为低风险社区诊所系统由非妇产科医生组成，使用统一的筛查和转诊协议。这些诊所的病人在UNC或WakeMed分娩。总体而言，WakeMed和北卡罗来纳大学的大多数产前患者都很贫困：北卡罗来纳大学的55%和WakeMed的64%有医疗补助或自费；45%的北卡罗来纳大学和36%的WakeMed有某种形式的私人保险。雷克斯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。雷克斯有一个大型的分娩中心和设施，来自威克县30多家私人诊所的患者在这里分娩。目前，我们在其他nih资助的研究中使用了18个这样的实践。与雷克斯的合作将进一步扩大我们的门诊招募基础。在我们的招聘中，种族和民族多样性很强，白人参与者占42%，西班牙裔参与者占29%，非裔美国人占27%。UNC和WakeMed有3级新生儿护理病房，Rex有2级托儿所。北卡罗来纳大学今年同时申请加入新生儿研究网络。作为MFMU的一部分，我们的三个合作机构共同带来了超过15年的多产的多站点研究，经验丰富的调查人员，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，以及对卓越合作研究的承诺。

DESCRIPTION (provided by applicant): As a new member of the Network, the UNC MFMU site has completed four randomized clinical trials and one observational study; is conducting follow-up studies for two trials; and has five trials ongoing. We have consistently ranked in the top half of overall recruitment among all network sites and excelled at Hispanic recruitment. 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, research 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, and specialized research services such as computer assisted telephone interviewing facilities, an NIH Clinical Nutrition Research Center, one of the top General Clinical Research Centers in the nation, a Comprehensive Center for Inflammatory Disorders, the Center for Oral and Systemic Diseases, and the Center for Women's Health Research. With the addition of Rex Healthcare in this application, our sites have more than 13,000 births each year, 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 our prenatal population because of a system of low-risk community clinics staffed by non-OB/GYNs using uniform screening and referral protocols. Patients from these clinics give birth at UNC or WakeMed. Overall, the majority of prenatal patients at WakeMed and UNC are indigent: 55% at UNC and 64% at WakeMed have Medicaid or are self-pay; 45% at UNC and 36% at WakeMed have some form of private coverage. The Rex patient population is predominately lower risk patients and the majority have some form of private coverage. Rex has a large birthing center and facilities where patients from more than 30 private practices in Wake County give birth. We currently work with 18 of these practices in other NIH-funded research. Affiliation with Rex will further broaden our base for outpatient recruitment. Racial and ethnic diversity in our recruitment has been strong with 42% white participants, 29% Hispanics, and 27% African Americans. UNC and WakeMed have Level 3 neonatal care units, and Rex has a Level 2 nursery. UNC is simultaneously applying to join the Neonatal Research Network this year. Together, our three partner institutions bring more than fifteen 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.