Columbia University Maternal-Fetal Medicine Units Network Clinical Center

抽象/项目总结

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.