NICHD Maternal-Fetal Medicine Units (MFMU) Network

 描述(由申请人提供)：产科的做法和治疗方法是传统的，通常在没有严格评估的情况下引入，基于“专家”的意见。做法往往受到媒体的影响，得到社会的认可，然后在没有评估风险或收益的情况下进入普通做法。因为产科经常影响两个病人，所以当一种新的干预措施、药物或设备被引入临床实践时，了解对两个人的潜在后果是很重要的。一种治疗可能对母亲有利但对胎儿有害，或者相反地对胎儿有利但对母亲有害。这些不良事件对家庭和社会都有社会和经济影响。此外，新的治疗干预措施可能与增加的医疗支出相关。需要确定这些社会和财政负担，以帮助塑造卫生保健政策和实践。自成立以来，尤尼斯·肯尼迪·施莱弗NICHD母胎医学部(MFMU)研究网络进行了临床试验和观察性研究，为我们对怀孕，特别是早产领域的理解提供了新的知识。过去的研究已经证明，17-羟基孕酮己酸酯可以降低早产的风险，而抗生素对早产后胎膜早破后的延长妊娠有好处。其他研究表明，胎儿脉搏血氧仪或胎心率ST段分析等新技术未能改变分娩结果。在过去24年中，网络研究在提供支持和反对许多做法的证据方面发挥了重要作用。在此应用程序中，我们演示了 凯斯西储大学(CWRU)生殖生物学系有能力进行合作研究，并成功地参与了MFMU的研究网络，因此有资格继续作为研究中心。我们的研究人员在临床试验和多中心研究方面拥有不同的背景，为未来和正在进行的研究提供了深入的经验。我们的中心在招聘和数据质量方面都表现良好，同时保持了较高的参与者留存率。CWRU社区(机构和政府)一直并将继续高度支持CWRU-MFMU研究中心及其调查人员。CWRU研究中心提供了领导，并参与了导致整个MFMU网络成功的行政操作。我们使用行政程序来改进招聘和降低成本，这是一种创新。CWRU提供强大的管理和研究基础设施，如Case-临床和转化科学合作，以支持我们的研究中心的运营。CWRU-研究中心团队处于理想位置，能够在即将到来的MFMU网络周期中提供卓越的领导能力。

 DESCRIPTION (provided by applicant): Obstetric practices and treatments are steeped in tradition, often introduced without rigorous evaluation based on "expert" opinion. Practices are often influenced by the media with societal acceptance then entering common practice without an assessment for risk or benefit. Because obstetrics often impacts two patients it is important to understand the potential consequences for both individuals when a new intervention, medication, or device is introduced into clinical practice. A treatment may benefit the mother but harm the fetus or inversely benefit the fetus but harm the mother. These adverse events have both social and financial implications for both the family and society. In addition, new therapeuti interventions can be associated with increased healthcare expenditures. These social and financial burdens need to be determined to help mold health care policy and practice. Since its inception, the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) research network has conducted clinical trials and observational studies that have provided new knowledge to our understanding of pregnancy especially in the area of prematurity. Past studies have demonstrated the benefit of 17-OH progesterone caproate to reduce the risk of preterm delivery and antibiotics to prolonged pregnancy after premature preterm rupture of the membranes. Other studies have demonstrated that new technologies such as fetal pulse oximetry or fetal heart rate ST segment analysis failed to change delivery outcomes. The network studies have played a significant role in providing evidence for and against many practices over the past 24 years. In this application, we demonstrate that the investigators in the Department of Reproductive Biology at Case Western Reserve University (CWRU) have the ability to conduct collaborative research, and have successfully participated in the MFMU research network and therefore qualify to continue on as a study center. Our investigators have a diverse background in clinical trials and multi-centered studies providing a depth of experience for future as well as on-going studies. Our center has performed well in both recruitment and data quality while maintaining high rates of participant retention. The CWRU community (institutional and governmental) has been and continue to be highly supportive of the CWRU-MFMU study center and its investigators. The CWRU study center has provided leadership and participated in the administrative operations that lead to the success of the entire MFMU network. Our use of administrative processes to improve recruitment and hold down costs has been innovative. CWRU provides a strong administrative and research infrastructure such as the CASE-Clinical & Translational Science Collaborative to support our study center operations. The CWRU-Study Center team is ideally positioned to provide leadership with exceptional performance in the coming MFMU Network cycle.