NICHD Maternal-Fetal Medicine Units (MFMU) Network

NICHD 母胎医学中心 (MFMU) 网络

• 批准号: 9078413
• 负责人: EDWARD K CHIEN
• 金额: $ 30.11万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9078413
• 关键词: Adverse event; Antibiotics; Area; Award; Capital; Cities; Clinical Research; Clinical Sciences; Clinical Trials; Collaborations; Communities; Conduct Clinical Trials; County; Data Quality; Development; Devices; Discipline of obstetrics; Educational process of instructing; Evaluation; Expenditure; Expert Opinion; Family; Fellowship; Fellowship Program; Fetal Heart Rate; Fetus; Future; Goals; Health Policy; Healthcare; Hospitals; Human Development; Individual; Institution; Intervention; Knowledge; Lead; Leadership; Location; Low Birth Weight Infant; Maternal-Fetal Medicine Units Network; Medical center; Methods; Molds; Morbidity - disease rate; Mothers; Multicenter Studies; National Institute of Child Health and Human Development; Neonatal; Observational Study; Ohio; Outcome; Participant; Patients; Performance; Pharmaceutical Preparations; Play; Population; Population Heterogeneity; Positioning Attribute; Poverty; Pregnancy; Premature Birth; Process; Productivity; Progesterone; Prolonged Pregnancy; Pulse Oximetry; Qualifying; Recording of previous events; Recruitment Activity; Reproductive Biology; Research; Research Infrastructure; Research Personnel; Resources; Retirement; Risk; Risk Assessment; Rivers; Role; Services; Side; Site; Societies; Time; Translational Research; United States National Institutes of Health; Universities; University Hospitals; Woman; Work; base; clinical practice; cost; dalton; eligible participant; experience; fetal; fetal medicine; follow-up; improved; innovation; maternal morbidity; medical schools; member; metropolitan; mortality; neonatal morbidity; new technology; operation; premature; preterm premature rupture of membranes; programs; public health relevance; retention rate; social; success; tertiary care

 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.

 描述（由申请人提供）：产科实践和治疗沉浸在传统中，通常没有基于“专家”意见进行严格评估。这些做法往往受到媒体的影响，得到社会的接受，然后在没有进行风险或效益评估的情况下进入普遍做法。由于产科通常会影响两名患者，因此当新的干预措施、药物或器械引入临床实践时，了解两个人的潜在后果非常重要。治疗可能有益于母亲但损害胎儿，或相反有益于胎儿但损害母亲。这些不良事件对家庭和社会都有社会和经济影响。此外，新的治疗干预可能与增加的医疗保健支出有关。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，Eunice Kennedy Shriver NICHD母胎医学单位（MFMU）研究网络进行了临床试验和观察性研究，为我们理解怀孕提供了新的知识，特别是在早产领域。过去的研究已经证明了17-OH孕酮己酸酯的好处，以减少早产的风险和抗生素，以延长妊娠后，过早的胎膜早破。其他研究表明，新技术，如胎儿脉搏血氧饱和度或胎儿心率ST段分析未能改变分娩结局。过去24年来，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。在这个应用程序中，我们证明，调查人员在 凯斯西储大学生殖生物学系（CWRU）有能力进行合作研究，并成功地参与了MFMU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具有多样化的背景，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保留率。CWRU社区（机构和政府）一直并将继续高度支持CWRU-MFMU研究中心及其研究人员。CWRU研究中心提供了领导，并参与了导致整个MFMU网络成功的行政运作。我们采用行政程序来改善招聘和降低成本，这是一种创新。CWRU提供了强大的行政和研究基础设施，如案例-临床和转化科学协作，以支持我们的研究中心的运作。CWRU研究中心团队的理想定位是在即将到来的MFMU网络周期中提供卓越表现的领导。