NICHD Maternal Fetal Medicine Units Network

描述(由申请人提供)：德克萨斯大学医学院(UTMB)拥有积极参与合作多中心MFMU网络所需的要素。乔治·萨德和候补PI加里·汉金斯在研究设计、招募、数据分析和多项NIH多点临床试验(非整倍体风险的早期和中期妊娠评估、产前硫酸镁的有益影响研究、双胞胎输血综合征试验、阴道超声环扎试验、静产协作研究网络、产科-胎儿药理研究单元网络、早产基因组/蛋白质组研究网络)发表文章方面具有丰富的经验。我们通过妇产科广泛的地区妇幼保健计划(RMCHP)成功地招募/留住患者。RMCHP每年为11,000多名多民族孕妇提供产前护理。所有RMCHP诊所都遵循母胎医学司制定的方案，所有产前和产中患者都在部门控制之下。我们的临床基础设施和患者群体使我们为参与该网络做好了充分准备，因为我们每年提供超过5,000例高危妊娠，其中90%以上在我们的系统中接受产前护理。该司的电子医疗记录系统(EMR)记录了产前和产中的数据，这些数据是在线输入的，随时可供授权研究人员查询和自动通知。与其他合作网站相比，电子病历和政策/程序已被成功调整，以最大限度地提高我们的研究效率。该部门的专职研究护士和协调员团队(主席研究部[CRD])和组织生物库，都在PI的指导下，扩大了临床研究的效率。这项申请的其他关键人员，包括我们部门主席Garland Anderson以及目前的MFMU网络，CRD护理总监Janet Brandon和CRD协调员Joan Moss，为团队带来了丰富的经验和专业知识。PI和候补PI之间出色而多产的合作，为该网络提供了进一步的好处和功效。我们的部门有一个富有成效和资金充足的基础科学研究小组，在许多与RFA相关的领域拥有专门知识。最后，我们与我们大学的新生儿科、遗传学、围产期病理学、临床实验室和放射科建立了良好的合作关系。在各级，UTMB强调总体研究，该网络拥有包括GCRC在内的多个核心设施，特别是产科研究(我部在全国NIH资金中排名第9，在德克萨斯州排名第1)。我们的概念方案比较了产前单疗程和多疗程皮质类固醇的有效性和安全性。我们接受RFA的强制和参与性规定，并随时准备作为该网络的富有成效的成员做出贡献。

DESCRIPTION (provided by applicant): The University of Texas Medical Branch (UTMB) has the required elements to actively participate in the Cooperative Multicenter MFMU Network. The PI, George Saade, and the alternate PI, Gary Hankins, bring extensive experience in study design, recruitment, data analysis, and publications from several NIH multisite clinical trials (First and Second Trimester Evaluation of Risk of Aneuploidy, Beneficial Effects of Antenatal Magnesium Sulfate Study, Twin-Twin Transfusion Syndrome Trial, Vaginal Ultrasound Cerclage Trial, Stillbirth Collaborative Research Network, Obstetric-Fetal Pharmacology Research Units Network, Genomic/Proteomic Network for Premature Birth Research). We achieve successful patient recruitment/retention through use of the Ob/Gyn Departments's broad Regional Maternal & Child Health Program (RMCHP). The RMCHP provides prenatal care to over 11,000 multiethnic pregnant women a year. All RMCHP clinics follow protocols set by the Maternal-Fetal Medicine Division, and all antepartum and intrapartum patients are under Departmental control. Our clinical infrastructure and patient population make us well prepared to participate in the Network as we deliver over 5,000 high-risk pregnancies a year, more than 90% receiving prenatal care in our system. The Department's Electronic Medical Record System (EMR) captures antepartum and intrapartum data, entered on-line and readily available to authorize research personnel for query as well as automatic notification. The EMR and policies/procedures have been successfully adapted to maximize our research productivity compared with other collaborating sites. The Department's team of dedicated research nurses and coordinators (Chairman's Research Division [CRD]) and the Tissue BioBank, both under the direction of the PI, have broadened efficiency in clinical investigations. Other key personnel in this application, including Garland Anderson, Chair of our Department as well as the current MFMU Network, Janet Brandon, CRD Nursing Director, and Joan Moss, CRD Coordinator, bring extensive experience and expertise to the team. The excellent and prolific collaboration between PI and alternate PI, who is also the MFM Division Director and RMCHP Medical Director, offers further benefit and efficacy to the Network. Our Department has a productive and well-funded basic science research group, with expertise in many areas of relevance to the RFA. Finally, we have well-established collaborative ties with our University's Divisions of Neonatology, Genetics, Perinatal Pathology, Clinical Laboratory, and Radiology. At all levels, UTMB emphasizes research in general, with multiple core facilities available to the Network including the GCRC, and obstetrical research in particular (our Department ranks 9th in NIH funding nationally, and 1 in Texas). Our concept protocol compares the efficacy and safety of single versus multiple courses of antenatal corticosteroids. We accept the RFA's capitation and participatory stipulations and stand ready to contribute as a productive member of the Network.