NICHD Maternal Fetal Medicine Units Network

描述(由申请人提供)：西北大学医学院母胎医学部对继续成为多中心母婴医学部的成员有浓厚的兴趣。我们再次希望参与使用共同方案的临床试验，重点是早产和导致新生儿死亡和发病率的其他情况。本申请描述了西北纪念医院(NMH)和埃文斯顿西北医疗保健(ENH)的MFM单位在网络活动中的合作努力计划。NMH和ENH是西北大学范伯格医学院的两个主要教学附属机构。这两个机构的产科和妇科的联合活动包括对医学生和住院医生的教育以及研究。我们已经展示了我们联合进行和参与随机试验和多中心研究的能力，这些试验和多中心研究涉及针对孕妇及其新生儿的详细研究程序。在本周期的MFMU网络中，ENH是通过分包合同安排增加为西北大学招聘地点的，目前在两个网络协议上进行招聘。提交本文件的计划是继续开展网络试验方面的合作，并将其扩大到所有正在进行的研究。我们相信，我们的优势在于我们在两个学术机构拥有庞大的患者基础，在研究方面有着良好的合作记录，我们敬业、创新的教职员工能够为网络研究议程的制定和优先事项提供新的方向。此外，我们拥有必要的研究基础设施，不仅能够招募和跟踪高危患者，而且还能够招募和跟踪私人和贫困患者，这将最大限度地将MFMU网络结果推广到所有面临不良围产期后果风险的人群。我们致力于在研究设计、方案执行、患者招募、数据分析和出版等领域与成员单位和网络工作人员合作。与公共健康相关-我们计划从两个大型学术医疗中心的不同患者群体中招募患者，参加多中心临床试验，调查临床产科的重要问题，如美国持续的高早产率。我们还计划以合作的方式参与网络的学习设计和其他功能。通过这种方式，我们希望为目前的临床困境提供答案，从而为新生儿和他们的母亲带来更好的患者护理和更好的临床结果。

DESCRIPTION (provided by applicant): The Section of Maternal-Fetal Medicine at Northwestern University Medical School has a strong interest in continuing as a member of the multicenter Network of Maternal-Fetal Medicine Units. We again wish to participate in clinical trials utilizing common protocols, with emphasis on the areas of preterm delivery and other conditions leading to neonatal mortality and morbidity. This application describes a plan for the cooperative efforts of the MFM units at both Northwestern Memorial Hospital (NMH) and at Evanston Northwestern Healthcare (ENH) in Network activities. NMH and ENH are the two primary teaching affiliates for the Northwestern University Feinberg School of Medicine. Combined activities of the Departments of Obstetrics and Gynecology at these two facilities include education of medical students and residents, as well as research. We have demonstrated our capabilities in jointly conducting and participating in randomized trials and multicenter studies that involved detailed study procedures for both pregnant women and their neonates. During this current cycle of the MFMU network, ENH was added as a Northwestern recruitment site through a subcontract arrangement, and recruitment is currently occurring on two network protocols. The plan for this submission is for cooperation in network trials to continue and to be expanded to all ongoing studies. We believe our strengths lie in our large patient base in two academic facilities with a proven record of cooperation in research, and our committed, innovative faculty capable of contributing new directions to the development and prioritization of a research agenda for the Network. Furthermore, we have the requisite research infrastructure that enables the recruitment and follow-up of not just high-risk patients, but private as well as indigent patients that will maximize the generalizability of MFMU Network results to the entire population at risk for adverse perinatal outcomes. We are committed to working cooperatively with member units and network staff in the areas of study design, protocol implementation, patient recruitment, data analysis and publication. Relevance to public health-We plan to recruit patients from a diverse patient population at two large academic medical centers to participate in multicenter clinical trials investigating important problems in clinical obstetrics, such as the persistent high rate of preterm birth in this country. We also plan to participate in study design and other functions of the network in a cooperative fashion. In this way we hope to provide answers to current clinical dilemmas, which will result in better patient care and improved clinical outcomes for both neonates and their mothers.