NICHD Maternal Fetal Medicine Units Network

描述（由申请人提供）：德克萨斯大学医学分部（UTMB）具有积极参与合作多中心MFMU网络所需的要素。首席研究员George Saade和副首席研究员Gary Hankins在研究设计、招募、数据分析和NIH多站点临床试验(妊娠早期和中期非整倍体风险评估、产前硫酸镁研究的有益影响、双胎输血综合征试验、阴道超声环扎试验、死产合作研究网络、产科-胎儿药理学研究单位网络、早产研究基因组/蛋白质组学网络)。我们通过使用妇产科广泛的区域妇幼保健计划（RMCHP）成功地招募/保留患者。该中心每年为1.1万多民族孕妇提供产前护理。所有RMCHP诊所都遵循母胎医学部制定的协议，所有产前和分娩患者都在该部门的控制之下。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的准备，因为我们每年为5000多名高危孕妇接生，90%以上的人在我们的系统中接受产前护理。该部门的电子医疗记录系统（EMR）捕获了产前和分娩时的数据，并在线输入，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，我们已经成功地调整了电子病历和政策/程序，以最大限度地提高我们的研究效率。该科的专门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，提高了临床研究的效率。其他关键人员，包括加兰·安德森，我们部门的主席以及目前的MFMU网络，珍妮特·布兰登，CRD护理主任，琼·莫斯，CRD协调员，为团队带来了丰富的经验和专业知识。PI和副PI（同时也是MFM部门主任和RMCHP医疗主任）之间出色而多产的合作为网络提供了进一步的好处和功效。我们系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相关的领域拥有专业知识。最后，我们与我校的新生儿科、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。在所有层面上，UTMB都强调一般的研究，有多个核心设施可供网络使用，包括GCRC，特别是产科研究（我们部门在NIH资助中排名全国第九，在德克萨斯州排名第一）。我们的概念方案比较了单疗程和多疗程的产前皮质类固醇的疗效和安全性。我们接受区域自由贸易区的出资和参与规定，并随时准备作为该网络的富有成效的成员作出贡献。

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.