Columbia University Maternal-Fetal Medicine Units Network Clinical Center

摘要/项目摘要 哥伦比亚中心在母胎医学部有20年的卓越记录 (MFMU)在大型多地点临床试验和纵向研究中的网络和合作 哺乳的人。在MFMU的上一轮比赛中，哥伦比亚中心在 为每一项研究招募人才。哥伦比亚中心将由哥伦比亚大学和3颗卫星组成 网站包括：Christian Care Health System、圣彼得大学医院和耶鲁大学纽黑文 在共同的行政和监督结构下运作的医院。加在一起，这四大- 批量分娩中心每年为23,500名种族和民族多样性的患者提供服务(24% 黑人，24%西班牙裔，9%亚裔)，社会经济地位，以及进入服务不足的社区的机会。结果 由于我们在每个地点都有强大的MFM、新生儿和专科护理和设施，我们40%的 总体而言，分娩人群是高风险人群。网络协议将在协调、严格和安全的情况下进行 由我们中心高素质的研究人员、工作人员、专门的MFMU设施和临床文化 研究是临床护理的一部分。哥伦比亚中心拥有合作的经验和专业知识 进行多点随机试验和大型观察性研究，及时招募、社区- 从不同的患者群体中招募符合条件的参与者，并具有出色的保留率和 严格收集数据，以促进结果，促进产科实践的进步。这个 哥伦比亚中心拥有众多优势，将提供产科方面的多学科专业知识， 新生儿学、产科药理学、婴儿神经发育和哺乳期临床实践 孕产妇死亡和与怀孕、分娩和产后恢复有关的并发症；减少 早产、低出生体重、婴儿死亡和婴儿并发症，并扩大关于 妊娠期和哺乳期用药的安全性和有效性。我们的中心拥有最先进的 网络研究的科学能力，包括成像、基因组学、蛋白质组学、胎盘功能 评估、创新的试验设计和分析，以及临床试验的专门支持。最后，我们的目标是 提供严谨的数据和生物样品收集，作为资源共享，供其他研究人员推进 循证产科实践。

Abstract/Project Summary The Columbia Center has a 20-year track record of excellence within the Maternal Fetal Medicine Units (MFMU) Network and collaborating in large multi-site clinical trials and longitudinal studies in pregnant and lactating people. During the last current cycle of the MFMU, the Columbia Center ranked near the top in recruitment for every study. The Columbia Center will be composed of Columbia University and 3 satellite sites including: Christiana Care Health System, Saint Peter's University Hospital, and Yale New Haven Hospital which operate under a common administrative and oversight structure. Together, these 4 large- volume delivery centers provide access to 23,500 patients annually with diversity in race and ethnicity (24% Black, 24% Hispanic, 9% Asian), socioeconomic status, and access to underserved communities. As a result of our strong presence of MFM, Neonatology and subspecialty care and facilities at each site, 40% of our overall delivery population is high-risk. Network protocols will be conducted in a coordinated, rigorous and safe manner by our Center's highly qualified investigators, staff, dedicated MFMU facilities and culture of clinical research being part of clinical care. The Columbia Center has the experience and expertise to collaboratively conduct multi-site randomized trials and large observational studies with timely recruitment, community- engaged enrollment of eligible participants from diverse patient populations with excellent retention and rigorous data collection to contribute to results which will promote advances in obstetric practice. The Columbia Center has numerous strengths and will provide multidisciplinary expertise on obstetrics, neonatology, obstetric pharmacology, infant neurodevelopment and lactation clinical practice to address maternal death and complications related to pregnancy, labor, and post-partum recovery; to reduce prematurity, low-birth weight, infant death, and infant complications and expand the evidence base about the safety and efficacy of medications used during pregnancy and lactation. Our Center has state-of-the-art scientific capabilities for Network research including imaging, genomics, proteomics, placental function assessment, innovative trial design and analyses, and specialized support of clinical trials. Lastly, our goal is to provide rigorous data and biospecimen collection to share as a resource for other investigators to advance evidence-based obstetric practice.