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单中心观察性研究或随机临床试验 (RCT)，可能不符合 CONSORT 声明 自 1986 年以来，MFMU 网络在关注主要原因的同时改善了这些缺点。 UT-休斯敦的 MFM 部门也有同样的愿景，并有成功参与和发表研究的承诺和良好记录。我们的部门 - 早产、胎儿生长异常、神经后遗症、产科并发症 - 与 NICHD 目标一致，因此，我们正在重新申请成为 MFMU 网络的积极参与者。 Chauhan 和候补 PI Baha M. Sibai 博士通过强调在试验和出版物中招募合格的女性，从文化上改变了该部门的文化，这些改进的例子是：在 2010 年的 APEX 和 SCAN 网络研究中，UT-休斯顿大学的招聘在 14 个中心中排名第 11 位。此后，我们筛选了 14,500 名女性，并招募了 1,767 名女性，现在，在 2015 年 5 月，我们在招聘网络中排名第 3 位。最近的 RCT-STAN、ALPS 和 ARRIVE 形成性变化的原因是：研究人员拥有 30 年的经验。从事 L&D 工作并担任研究人员 21 年；促进合格女性的筛选和招募；最近招募了 14 名热衷于临床试验的 MFM。 我们的成功是因为增加了两个新的官方站点，每年增加 8,300 次交付，从战略上确保 PI 和 MFM 新站点的每周临床职责有利于 MFM 教职人员和 L​​&D 研究员每天在主中心进行招聘；这增强了网络和其他资助研究的招募和合规性。我们致力于试验的客观证据是，自 2011 年以来，我们部门的 MFM 已发表 256 篇文章，其中 88 篇是多中心、 52 项关注产科并发症，42 项关注早产或早产，18 项关注胎儿生长异常，14 项关注神经系统后遗症，以及 6 项随机对照试验 除网络研究外，MFM 教师目前还参与了 8 项随机对照试验，其中 6 项是多中心的。我们还对纳米载体进行过渡性研究，以防止宫胎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正在进行中。总之，由于招聘和出版物的记录以及持续改进的基础设施，德州大学休斯顿分校应该继续成为 MFMU 网络的重要组成部分。