Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)Activity Code

项目摘要 无论怀孕是高风险还是低风险，影响 在美国，每年超过370万名新生儿的管理通常是基于回顾数据。因此， 需要前瞻性地从多中心或在可行的情况下从随机临床试验中收集数据 (RCT)，具有公正的治疗效果。在过去的19年里，德克萨斯大学休斯顿分校(UTH)一直是 母婴医学部(MFMU)网络的重要组成部分，以获取公正的数据。 UTH研究团队由11人组成，拥有84年的指挥经验 研究和100多年来在分娩和分娩方面的工作。确定参与网络的优先顺序是 在我们的部门里根深蒂固。我们的主席和MFM联谊会主任都曾担任网络PI和 交替交点。在我们的部门内，我们有37年的PI或替补PI的经验。为 目前在12个网络中心中有4个RCT，我们招聘合格人员的排名在第1到第4位之间 而且，我们对随机参加这些试验的人数的排名在第二到第五之间。我们的人 网络试验招募人员在3家医院分娩，每年有超过11,000名新生儿出生。这个 我们管理的大多数人都是种族和民族多元化的，所以超过85%的人被招募到 正在进行的MFMU研究是代表不足的少数民族。 我们的随访率一直保持在90%以上，除了阿尔卑斯山儿童的随访率。我们 采取了几项措施来提高随访率。我们正试图在下班后联系家属 或者在周末，提供周六的学习访问预约，并增加我们对社交媒体的使用。我们 继续完善我们的战略，以优化随访率。 要想成为网络中有价值的成员，中心必须有学术生产力的证据。 自2016年以来，我们发表了260多篇同行评议文章，这些文章与 MFMU网络。在过去的5年里，UTH的教职员工发表了14篇随机对照试验，其中有11项试验(78%) 是多中心的。如果该网络要颠覆国家指南对回溯性研究的依赖， 中心必须鼓励和聘用研究员和初级教员进行假设生成二级 分析和RCT。独立于网络，我们最近发表了12项二级分析，我们的MFM 研究员正在进行6项随机对照试验，这些试验不与MFMU试验竞争。值得注意的是，对于 即将到来的Network试验--剖腹产试验后的处方--是我们一位新近毕业的学生发表的一篇随机对照试验 研究金(Dinis J等人)我是J·奥布斯特特·吉内科尔。2020)。 我们继续致力于确保研究的适当进行，保持我们的表现在 各方面的前半部分，包括合格率、随机化率、随访率和资料质量优劣。

Project Summary Irrespective of whether the pregnancy is high- or low-risk, the national guidelines influencing the management of upwards of 3.7 million births in the US annually are often based on retrospective data. Hence, the need for prospectively collected data from multiple-centers or, whenever feasible, randomized clinical trials (RCT), with unbiased treatment effect. For the last 19 years University of Texas-Houston (UTH) has been a vital part of Maternal-Fetal Medicine Units (MFMU) Network to garner unbiased data. The UTH research team consists of 11 people, with combined experience of 84 years conducting research and over 100 years of working on labor and delivery. Prioritizing participation in the Network is ingrained in our Division. Our Chair and the MFM Fellowship Director have both served as Network PI and alternate PI. Within our Division we have a combined experience of being PI or alternate PI for 37 years. For the current 4 RCT, out of the 12 Network centers, our recruitment of eligible people ranks between 1st and 4th and, our ranking for the number of people randomized to these trials is between 2nd and 5th. The people we recruit for the Network trials deliver at 3 hospitals, with upwards of 11,000 combined births annually. The majority of the individuals we manage are racially and ethnically diverse, so over 85% of those recruited for the ongoing MFMU studies are underrepresented minorities. Our follow-up rates have been consistently greater 90%, except for the follow-up of ALPS children. We have taken several measures to increase follow-up rates. We are attempting to contact the families after hours or on weekends, offering Saturday appointments for study visits, and increasing our use of social media. We continue to refine our strategies to optimize follow-up rates. To be a valuable member of the Network, the center must have evidence of academic productivity. Since, 2016, we have published over 260 peer-reviewed articles, which were congruent with the aims of the MFMU Network. In the last 5 years, UTH faculty and Fellows have published 14 RCT, with 11 trials (78%) being multi-centered. If the Network is to upend the national guidelines' reliance on retrospective studies, centers must encourage and engage Fellows and junior faculty to undertake hypothesis generating secondary analyses and RCT. Independent of the Network, we recently published 12 secondary analyses, and our MFM Fellows are conducting 6 RCT, which do not compete with MFMU trials. It's notable that a nidus for the upcoming Network trial—Prescription After Cesarean Trial—was an RCT published by a recent graduate of our fellowship (Dinis J et al. Am J Obstet Gynecol. 2020). We remain committed to ensuring proper conduct of the studies, maintaining our performance ranks in the top-half of all aspects, including rate of eligible people randomized, follow-up and data quality merits.