NICHD Maternal-Fetal Medicine Units (MFMU) Network

 描述(由申请人提供)：产科指南中的建议通常基于单中心观察性研究或随机临床试验(RCT)，这可能不符合CONSORT声明。自1986年以来，MFMU网络改善了这些缺陷，同时重点关注孕产妇-新生儿发病率的主要原因。德克萨斯大学休斯顿分校的MFM部门也有同样的愿景，有承诺，并在成功参与和出版方面有良好的记录。我们部门的研究--早产、胎儿发育异常、神经后遗症、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.Sibai博士，通过在试验和出版物中强调招募合格女性，在文化上改变了该部门。这些改进的例证是，在2010年的网络研究APEX和SCAN中，德克萨斯大学休斯顿分校的招聘在14个中心中排名第11。从那时起，我们筛选了14,500名女性，招募了1,767名女性。现在，在2015年5月，我们在最近的RCT招聘网络中排名第三-斯坦，阿尔卑斯山，并到达。形成变化的原因是：在L研发公司拥有30年经验和21年研究人员的研究人员；为筛选和招募合格女性提供便利的基础设施；最近招聘的14名MFM对临床试验充满热情。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人次；从战略上确保PI和MFM新网站每周的临床责任，有利于招聘；MFM教员和研究员在主中心的L&D，这提高了招聘和合规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发表了256篇文章，其中88篇是多中心的，52篇是关于产科并发症的，42篇是关于早产或分娩的，18篇是关于胎儿生长异常的，14篇是关于神经后遗症的，6篇是随机对照试验。除了网络研究，MFM教员目前还参与了八个随机对照试验，其中六个是多中心的。我们还进行了纳米载体的过渡性研究，以防止胎儿手术后胎盘转移和早产儿并发症。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。总而言之，由于招聘和出版物的良好记录，作为继续改进的基础设施，休斯顿大学应该继续成为MFMU网络的重要组成部分。

 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.