NICHD Maternal-Fetal Medicine Units (MFMU) Network

NICHD 母胎医学中心 (MFMU) 网络

• 批准号: 9910067
• 负责人: Suneet P Chauhan
• 金额: $ 29.26万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 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/9910067
• 关键词: Achievement; Case-Control Studies; Clinical; Clinical Research; Clinical Trials; Communication; Consent; Discipline of obstetrics; Enrollment; Ensure; Faculty; Fetal Growth; Funding; Future; Goals; Growth; Guidelines; Hospitals; Infrastructure; Maternal-Fetal Medicine Units Network; Medical; Mission; Multi-Institutional Clinical Trial; Multicenter Studies; National Institute of Child Health and Human Development; Neurologic; Observational Study; Outcome; Participant; Persons; Population; Pregnancy; Premature Birth; Premature Labor; Prevention; Principal Investigator; Protocols documentation; Publications; Publishing; Randomized Clinical Trials; Recommendation; Research; Research Personnel; Site; Texas; Tocolytic Agents; Translating; Universities; Vision; Woman; base; bilingualism; experience; fetal; fetus surgery; follow-up; improved; member; nanovector; neonatal encephalopathy; neonatal morbidity; obstetrical complication; placental transfer; premature; preterm premature rupture of membranes; prevent; protocol violation; public health relevance; randomized trial; recruit; screening; success

 DESCRIPTION (provided by applicant): Recommendations in obstetric guidelines are often based on single center observational studies or randomized clinical trials (RCTs) that may not be compliant with CONSORT statement. Since 1986, the MFMU Network has ameliorated these shortcomings while focusing on leading causes of maternal-neonatal morbidity. The MFM Division at UT- Houston shares this vision, has commitment and a proven track record of successfully participating in, and publication. Research in our division-preterm labor, fetal growth abnormalities, neurological sequelae, obstetric complications-is congruent with NICHD goals. Hence, we are reapplying for the fourth cycle to be an active participant of the MFMU Network. Our PI, Dr. Suneet P. Chauhan, and alternate PI, Dr. Baha M. Sibai, have culturally transformed the division by emphasizing recruitment of eligible women in trials and publications. These improvements are exemplified by the fact that for both in APEX and SCAN, the Network studies in 2010, UT-Houston recruitment was ranked 11th out of 14 centers. Since then we have screened 14,500 women, and recruited 1,767. Now, in May 2015, we were ranked 3rd in the Network for recruitment of the recent RCTs-STAN, ALPS, and ARRIVE. The reasons for the formative changes are: research staff with 30 years of experience in L&D and 21 years as researchers; infrastructure which facilitates screening and enrollment of eligible women and; recent recruitment of 14 MFM enthusiastic about clinical trials. In the coming years, we will build on our success because of the addition of two new official sites, with 8,300 additional deliveries annually; strategically ensuring weekly clinical responsibilities at the new sites of PI and MFM conducive to recruitment; daily presence of MFM faculty and fellows on L&D at the main center, which enhances recruitment and compliance with Network and other funded studies. The objective evidence of our commitment to trials is that since 2011, MFM in our division has published 256 articles, with 88 being multi-center, 52 focused on obstetric complications, 42 on preterm labor or birth, 18 on fetal growth abnormalities, 14 on neurologic sequelae and 6 RCT. In addition to Network studies, MFM faculty is currently involved in eight RCTs, six of which are multi-center. We also have transitional research on nanovectors to prevent placental transfer of tocolytics and complications of prematurity following fetal surgery. While committed to these studies, we are cognizant of Network studies being the top priority. In summary, because of the proven record of recruitment and publications, an infrastructure for continued improvement, UT-Houston should continue to be vital part of MFMU Network.

 描述（由申请人提供）：产科指南中的建议通常基于可能不符合CONSORT声明的单中心观察性研究或随机临床试验（RCT）。自1986年以来，MFMU网络改善了这些缺陷，同时重点关注产妇-新生儿发病率的主要原因。在UT-休斯顿的MFM部门分享这一愿景，有承诺和成功参与和出版的良好记录。我们部门的研究-早产，胎儿生长异常，神经系统后遗症，产科并发症-与NICHD的目标一致。因此，我们正在重新申请第四个周期成为MFMU网络的积极参与者。我们的PI，Suneet P. Chauhan博士和候补PI，Baha M博士。Sibai通过强调在试验和出版物中招募合格的妇女，从文化上改变了该部门。这些改进的例子是，在APEX和SCAN，网络研究在2010年，UT休斯顿招聘排名第11位的14个中心。从那时起，我们筛选了14 500名妇女，招募了1 767名。现在，在2015年5月，我们在最近的RCTs-STAN，ALPS和ARRIVE招募网络中排名第三。形成变化的原因是：研究人员在L&D有30年的经验和21年的研究人员;基础设施，有利于筛选和合格的妇女登记;最近招募了14名热衷于临床试验的MFM。在未来几年，我们将建立 我们的成功是因为增加了两个新的官方网站，每年增加8，300次交付;战略性地确保PI和MFM新网站的每周临床责任有利于招聘; MFM教师和研究员在主要中心的L&D的日常存在，这增强了招聘和遵守网络和其他资助的研究。我们致力于试验的客观证据是，自2011年以来，我们部门的MFM已经发表了256篇文章，其中88篇是多中心的，52篇关注产科并发症，42篇关注早产或分娩，18篇关注胎儿生长异常，14篇关注神经系统后遗症，6篇RCT。除了网络研究，MFM教师目前参与了八项RCT，其中六项是多中心的。我们还对纳米载体进行了过渡性研究，以防止宫缩抑制剂的胎盘转移和胎儿手术后的早产并发症。在致力于这些研究的同时，我们认识到网络研究是重中之重。总之，由于在招聘和出版方面的良好记录，以及持续改进的基础设施，UT休斯顿应该继续成为MFMU网络的重要组成部分。