NICHD Maternal Fetal Medicine Units Network

NICHD 母胎医学单位网络

• 批准号: 7220075
• 负责人: YORAM SOROKIN
• 金额: $ 45.04万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7220075
• 关键词: African American; Ancillary Study; Area; Biological; Caucasians; Caucasoid Race; Clinic; Clinical; Clinical Research; Collaborations; Commit; Data; Data Quality; Databases; Double-Blind Method; Encephalopathies; Enrollment; Equipment; Evaluation; Faculty; Fetus; Foundations; Funding; Genetic; Goals; Grant; Health; Hemorrhage; Hospitals; Hydroxyprogesterone Caproate; Joints; Journals; Knowledge; Leadership; Liquid substance; Manuscripts; Measures; Medical center; Medicine; Minority; Multicenter Studies; Multicenter Trials; National Institute of Child Health and Human Development; Neonatal; Numbers; Nursing Research; Omega-3 Fatty Acids; Outcome; Paper; Patient Selection; Patients; Peer Review; Performance; Perinatal; Placebo Control; Population; Pregnancy; Pregnancy loss; Pregnant Women; Premature Birth; Prematurity of fetus; Prevention strategy; Principal Investigator; Problem Solving; Productivity; Prospective Studies; Protocols documentation; Publications; Publishing; Qualifying; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Range; Rate; Recruitment Activity; Research; Research Design; Research Personnel; Research Proposals; Resources; Risk; Role; Screening procedure; Second Pregnancy Trimester; Site; Staging; Survival Analysis; Testing; Time; Treatment Effectiveness; Universities; Vagina; Week; Woman; abstracting; base; computerized; concept; design; expectation; experience; fetal; follow-up; improved; innovation; member; neonate; skills; success

DESCRIPTION (provided by applicant): Project Summary: The objective of this application is for Wayne State University (WSU) to continue as a Maternal-Fetal Medicine Unit (MFMU) Network site. We are committed to cooperative research and offer a large patient base (9,800 deliveries/year), including a high percentage of minorities, from which to enroll into network protocols. We propose to achieve this objective with WSU MFMU highly qualified research team, which has strong leadership, with knowledge and experience in research design and collaboration in multicenter randomized clinical trials, as well as adequate time commitment and resources for performance of Network studies. Our capability and intent of recruitment, rigorous patient evaluations and treatment of subjects using common protocols are documented by both current status and past performance. WSU is tied for 4th in ranking for enrollment during the current cycle. WSU contributed 23.8% of pregnant women of African American descent into MFMU studies. It is our expectation that we will continue to be an integral and contributing member of the MFMU in research, identified by other members as innovators of new projects. Sixteen subspecialists in maternal-fetal medicine (three also subspecialized in clinical genetics), and two neonatologists will collaborate in the MFMU Network Center. Our computerized perinatal database now contains over 145,736 deliveries. Our long-range research goal is to develop strategies for the prevention of preterm birth. The central hypothesis of the concept proposal is that treatment with 17 Hydroxyprogesterone Caproate (17-OHP) reduces the risk of preterm birth in women who have previously experienced a midtrimester spontaneous pregnancy loss, or experience mid-trimester vaginal bleeding in the current pregnancy. The specific aims are to identify women with a spontaneous pregnancy loss at 13-20 weeks in prior pregnancy or with presence of vaginal bleeding at 13-20 weeks in the current pregnancy, and to test the effectiveness of treatment with 17-OHP to reduce the rate of PTB. The concept proposal is a randomized, double-blind, placebo controlled, multicenter trial. The proposed research is innovative for its study design, patient selection, and utility of survival analysis. The outcomes will be significant because the will provide stronger foundation for treatment with 17-OHP. Our application and research proposal will reduce preterm delivery, and improve the health of pregnant women, their fetuses, and neonates.

描述（由申请人提供）： 项目摘要：本申请的目的是让韦恩州立大学 (WSU) 继续作为母胎医学单位 (MFMU) 网络站点。我们致力于合作研究，并提供庞大的患者基础（每年 9,800 例分娩），其中包括高比例的少数族裔，可以从这些患者中加入网络协议。我们建议通过 WSU MFMU 高素质的研究团队来实现这一目标，该团队拥有强大的领导能力，在多中心随机临床试验的研究设计和协作方面拥有知识和经验，以及进行网络研究的足够的时间投入和资源。我们的招募能力和意图、严格的患者评估以及使用通用方案对受试者进行治疗均由当前状态和过去的表现记录下来。华盛顿州立大学在本周期的入学排名中并列第四。 WSU 将 23.8% 的非裔美国孕妇纳入 MFMU 研究。我们期望我们将继续成为 MFMU 研究领域不可或缺的贡献成员，并被其他成员视为新项目的创新者。 16 名母胎医学专科医生（其中 3 名专攻临床遗传学）和 2 名新生儿科医生将在 MFMU 网络中心进行合作。我们的计算机化围产期数据库目前包含超过 145,736 次分娩。我们的长期研究目标是制定预防早产的策略。该概念提案的中心假设是，17 羟孕酮己酸酯 (17-OHP) 治疗可降低曾经历过中期自然流产或当前妊娠中期阴道出血的女性早产的风险。具体目的是识别前次妊娠 13-20 周时发生自然流产或当前妊娠 13-20 周时出现阴道出血的女性，并测试 17-OHP 治疗的有效性，以减少PTB 率。该概念提案是一项随机、双盲、安慰剂对照、多中心试验。拟议的研究在研究设计、患者选择和生存分析的实用性方面具有创新性。结果将是显着的，因为这将为 17-OHP 治疗提供更坚实的基础。我们的应用和研究计划将减少早产，改善孕妇、胎儿和新生儿的健康。