Co-Operative Multicenter Trials in Obstetrics & Maternal Fetal Medicine

描述(由申请者提供)：本申请的目标是让韦恩州立大学(WSU)继续作为母婴医学部(MFMU)的网站。就MFMU网络的学术效率而言，WSU在患者招募和保留/完成方面排名居中，在遵从性/数据质量方面排名5.5，在TSH试验中对婴儿进行了100%的12个月和24个月的随访。在当前资助周期启动的2个随机对照试验中，14个MFMU中心登记的非裔美国患者中，WSU贡献了不成比例的高数量(21%)。WSU首席调查员参加了各委员会和小组委员会，并对TSH议定书的研究开发和设计作出了贡献。WSU调查人员提交了10份提案，并首先撰写了6份MFMU出版物。西澳州立大学MFMU团队凭借在研究设计方面拥有知识和经验的高素质领导层，以及在多中心随机临床试验方面的合作，在拥有广泛研究基础设施的情况下，拥有经验丰富的研究人员，实现了这些目标。WSU首席调查员将他的保护时间增加到50%，致力于MFMU相关活动，并正在增加2个地点，这将使WSU可用于MFMU招募的患者人数增加70%，达到每年9418次分娩。这3个地点的卫生保健提供者被要求向所有患者提供筛查和登记参加研究的机会。母胎工作人员，包括13名教员和7名研究员，效率很高，发表了265篇同行评议的出版物，并为11项合作或多中心设计的非MFMU研究做出了贡献。自1986年以来，西澳州立大学一直是NICHD新生儿研究网络的一个中心。大型高质量围产期数据系统帮助编写了这一应用程序，并为MFMU研究护士登记的MFMU患者提供了独特的通知系统。特别的优势包括具有研究管理经验的教员、莫特研究中心和NICHD围产期研究分会。我们概念提案的中心假设是，使用阿奇霉素治疗将降低因临床指征而接受中期基因羊膜穿刺术并通过聚合酶链式反应(PCR)在羊水中检测解脲支原体的妇女的自发早产(SPTB)风险。概念提案是一项随机、双盲、安慰剂对照的多中心试验。提出的研究具有创新性。结果可能改变实践，为临床指征羊膜穿刺术中获得的房颤的常规聚合酶链式反应检测、抗生素的应用和减少肺结核的发生提供了坚实的基础。这项研究提案预计将减少肺结核，并改善孕妇及其新生儿的健康。

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.