NICHD Maternal-Fetal Medicine Units (MFMU) Network

项目总结/摘要 在过去的20年里，北卡罗来纳州查佩尔山大学（中心27）已经证明了其承诺 作为产妇胎儿医学单位网络（MFMU）的成员，通过有效地进行临床试验， 优秀的受试者招募和保留，以及高数据质量。该机构已完成17项研究， 目前有10项正在进行中，包括一项COVID-19研究和今年批准的另外两项研究。我们平均 在所有研究中心中，招募总体排名第7，保留/完成排名第7。 在我们的研究联盟中，医疗保健与其他三个卫生系统一起担任牵头组织 作为卫星--北卡罗来纳州罗利的维克健康和医院;达勒姆的杜克健康和医院;以及棱镜 卫生系统在格林维尔，南卡罗来纳州。总的来说，我们经营八个劳动和交付单位，一个独立的分娩 中心和五个新生儿重症监护病房，每个系统都有一个新生儿重症监护病房后续诊所的毕业生。 我们的区域范围抽样框架使我们能够接触到几乎每一个出生和母亲和她的婴儿在 “三角”，北卡罗来纳州的皮埃蒙特地区，人口超过200万。Prisma Health在 格林维尔，南卡罗来纳州作为一个卫星站点，我们平均>25,000出生跨站点，其中>30%被认为是高- 由于母体合并症，包括药物滥用、胎儿畸形、妊娠并发症， 或早产风险分析。这四个提供全面服务的卫生系统所服务的人口具有种族多样性， 其中约11%的参与者是西班牙裔，包括各种社会经济地位的家庭。我们 是唯一一个拥有基于人口的招聘环境的网络中心。这些医疗保健 系统带来了超过30年的多站点研究，经验丰富的调查人员，最先进的 护理设施，稳定的人口，以及作为MFMU网络积极参与者的卓越承诺。 我们联盟中的所有卫生系统都依赖Epic作为其电子健康记录的选择，在过去的五年里， 多年来，我们的团队已经开发了手册和协议，以促进患者招募，数据摘要和数据 共享随着COVID导致每个研究中心的研究停止（3月13日至6月1日），招募工作放缓 下来然而，我们继续努力，并修改了我们的协议，以确保持续的生产力。 在这份提案中，我们将描述我们的计划，以保持我们的成功记录，完成正在进行的研究， MFMU网络。我们久经考验的业绩记录，加上我们庞大而多样化的潜在研究基础， 参与者以及我们对临床试验和观察性研究的了解将使我们能够继续我们的研究 为MFMU网络研究的质量和数量做出实质性贡献。

PROJECT SUMMARY/ABSTRACT Over the past 20 years, University of North Carolina at Chapel Hill (UNC) (Center 27) has proven its commitment as a member of the Maternal Fetal Medicine Unit Network (MFMU) by conducting clinical trials with efficiency, excellent subject recruitment and retention, and high data quality. The UNC MFMU has completed 17 studies, with 10 currently active, including a COVID-19 study and two others that were approved this year. We average 7th overall in recruiting among all sites, and #7 in retention/completion. UNC Health Care serves as the lead organization in our consortium for research, with three other health systems as satellites--Wake Health and Hospitals in Raleigh, NC; Duke Health and Hospitals in Durham; and the Prisma Health System in Greenville, SC. Collectively, we operate eight labor and delivery units, one free standing birth center, and five neonatal intensive care units with each system having an NICU follow up clinic for graduates. Our region-wide sampling frame affords us access to virtually every birth and mother to be and her baby in the “Triangle”, a region in the Piedmont of North Carolina with a population of >2 million. With Prisma Health in Greenville, SC as a satellite site, we average >25,000 births across sites, of which >30% are considered high- risk because of maternal co-morbidities, including substance abuse, fetal anomalies, pregnancy complications, or preterm birth risk profile. The population served by these four full service health systems is ethnically diverse, with ~11% of our participants being Hispanic, and includes families at a full range of socioeconomic status. We are the only Network center to have a population-based context in which to recruit. Together, these health care systems bring more than 30 years of productive multi-site research, experienced investigators, state-of-the-art care facilities, a stable population, and a commitment to excellence as an active participant in the MFMU network. All Health Systems in our coalition rely on Epic as their electronic health record of choice, and over the past five years our team has developed manuals and protocols to facilitate patient recruitment, data abstracting, and data sharing. With COVID causing a shutdown in research at each site (~March 13-June 1), recruitment has slowed down. However, we have continued working and have modified our protocols to ensure continued productivity. In this proposal we will describe our plans to maintain our record of success by completing ongoing studies of the MFMU Network. Our proven record of performance, coupled with our large, diverse base of potential study participants and our knowledge of clinical trials and observational studies will enable us to continue our substantive contribution to the quality and quantity of research in the MFMU Network.