Co-Operative Multicenter Trials in Obstetrics & Maternal Fetal Medicine

产科合作多中心试验

• 批准号: 8281686
• 负责人: YORAM SOROKIN
• 金额: $ 7.49万
• 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 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8281686
• 关键词: Accounting; Address; Adherence; African American; Amniocentesis; Amniotic Fluid; Antibiotic Therapy; Antibiotics; Azithromycin; Cerebral Palsy; Child; Clinical; Clinical Research; Collaborations; Commit; Data Quality; Disabled Persons; Discipline of obstetrics; Double-Blind Method; Enrollment; Experimental Models; Faculty; Fetal Growth; Fetal Tissues; Fetus; Foundations; Funding; Genetic; Goals; Health; Health Personnel; Infant; Infection; Infection of amniotic sac and membranes; Inflammation; Information Systems; Intervention; Investigation; Knowledge; Leadership; Macaca mulatta; Masks; Maternal Complication of Pregnancy; Minority; Morbidity - disease rate; Mothers; Multicenter Trials; National Institute of Child Health and Human Development; Neonatal; Neonatal Mortality; Neurologic; Notification; Nursing Research; Omega-3 Fatty Acids; Organism; Outcome; Patient Recruitments; Patients; Peer Review; Performance; Perinatal; Perinatology; Placebo Control; Placebos; Polymerase Chain Reaction; Pregnancy; Pregnant Women; Premature Birth; Premature Labor; Prevention; Principal Investigator; Process; Productivity; Protocols documentation; Publications; Qualifying; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Research Proposals; Resources; Risk; Screening procedure; Second Pregnancy Trimester; Site; System; Testing; Time; United States; Universities; Ureaplasma; Ureaplasma urealyticum; Ursidae Family; Woman; Writing; base; clinical practice; cooperative study; cost; cost effective; design; evidence base; experience; fetal; fetal medicine; follow-up; handicapping condition; improved; innovation; meetings; microorganism; mortality; neonatal death; neonatal morbidity; neonate; patient population; preterm premature rupture of membranes; prevent; primary outcome; randomized trial; research and development; research study

DESCRIPTION (provided by applicant): The objective of this application is for Wayne State University (WSU) to continue as a Maternal-Fetal Medicine Unit (MFMU) network site. With respect to academic productivity in the MFMU network WSU is ranked in the middle for patient recruitment and retention/completion, and 5.5 in adherence/data quality, with 100% 12 and 24 months infant follow-up in the TSH trial. WSU contributed a disproportionately high number (21%) of African American patients enrolled, by the 14 MFMU centers, to the 2 RCTs initiated in the current funding cycle. The WSU Principal Investigator participated in Committees and Subcommittees, and contributed to research development and design of the TSH protocol. WSU investigators submitted 10 proposals and first authored 6 MFMU publications. The WSU MFMU team achieved the objectives with highly qualified leadership that has knowledge and experience in research design, and collaboration in multicenter randomized clinical trials, experienced research staff, in the presence of extensive research infrastructure. The WSU Principal Investigator increased his protected time to 50%, dedicated to MFMU related activities, and is adding 2 sites, which will increase the patient population available at WSU for MFMU recruitment by 70% to 9418 deliveries/year. Health care providers in the 3 sites are required to provide access to all patients for screening and enrollment to research studies. Maternal-fetal staff, including 13 faculty and 7 fellows, are very productive with 265 peer-reviewed publications, and contribution to 11 non-MFMU studies of cooperative or multicenter design. WSU has been a center in the NICHD Neonatal Research Network since 1986. The large high quality perinatal data system assisted in writing this application, and has a unique notification system for MFMU research nurses of MFMU enrolled patients. Special strengths include faculty with experience in research administration, the Mott center for research, and the NICHD Perinatology Research Branch. The central hypothesis of our concept proposal is that treatment with azithromycin will reduce the risk of spontaneous preterm birth (SPTB) among women that (Uu) undergo mid-trimester genetic amniocentesis for clinical indications, and have Ureaplasma urealyticum detected in amniotic fluid, by polymerase chain reaction (PCR). The concept proposal is a randomized, double-blind, placebo controlled, multicenter trial. The proposed research is innovative. Results could change practice, by providing a strong foundation for routine PCR testing of AF obtained during amniocentesis for clinical indications, administration of antibiotics, and reduction in PTB. The research proposal is expected to reduce PTB and improve the health of pregnant women their neonates.

描述（由申请人提供）：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) 网站。就 MFMU 网络的学术生产力而言，WSU 在患者招募和保留/完成方面排名中间，在依从性/数据质量方面排名 5.5，在 TSH 试验中 12 和 24 个月婴儿随访率为 100%。 WSU 在当前资助周期启动的 2 项随机对照试验中，由 14 个 MFMU 中心招募的非裔美国患者数量异常高（21%）。 WSU 首席研究员参加了委员会和小组委员会，并为 TSH 方案的研究开发和设计做出了贡献。 WSU 的研究人员提交了 10 份提案并第一作者了 6 份 MFMU 出版物。 WSU MFMU 团队凭借高素质的领导层实现了这些目标，他们在研究设计、多中心随机临床试验协作方面拥有知识和经验，经验丰富的研究人员以及广泛的研究基础设施。 WSU 首席研究员将其受保护时间增加到 50%，致力于 MFMU 相关活动，并增加了 2 个站点，这将使 WSU 可用于 MFMU 招募的患者人数增加 70%，达到每年 9418 例分娩。这 3 个地点的医疗保健提供者必须为所有患者提供筛查和登记研究的机会。母胎工作人员，包括 13 名教职人员和 7 名研究员，发表了 265 篇同行评审出版物，并为 11 项非 MFMU 合作或多中心设计研究做出了贡献。自 1986 年以来，WSU 一直是 NICHD 新生儿研究网络的中心。大型高质量围产期数据系统协助编写了本申请，并为 MFMU 入组患者的 MFMU 研究护士提供了独特的通知系统。特殊优势包括具有研究管理经验的教师、莫特研究中心和 NICHD 围产期研究分部。我们概念提案的中心假设是，阿奇霉素治疗将降低妇女自发性早产 (SPTB) 的风险，这些妇女 (Uu) 因临床指征而接受妊娠中期遗传性羊膜穿刺术，并通过聚合酶在羊水中检测到解脲支原体链式反应（PCR）。该概念提案是一项随机、双盲、安慰剂对照、多中心试验。拟议的研究具有创新性。结果可以改变实践，为羊膜穿刺术中获得的 AF 常规 PCR 检测提供坚实的基础，以用于临床适应症、抗生素的使用和减少 PTB。该研究提案预计将减少 PTB 并改善孕妇及其新生儿的健康。