NICHD Maternal Fetal Medicine Units Network

NICHD 母胎医学单位网络

• 批准号: 7221901
• 负责人: GEORGE R. SAADE
• 金额: $ 63.38万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-15 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7221901
• 关键词: Adrenal Cortex Hormones; Age; Age-Years; Aneuploidy; Area; Basic Science; Cardiac; Cephalic; Chairperson; Child; Clinic; Clinical; Clinical Pathology; Clinical Research; Clinical Trials; Collaborations; Communities; Computerized Medical Record; Congenital Heart Defects; Core Facility; Data; Data Analyses; Data Quality; Development; Discipline of obstetrics; Down Syndrome; Early Diagnosis; Echocardiography; Elements; Enrollment; European; Evaluation; Fetofetal Transfusion; Fetus; First Pregnancy Trimester; Funding; Genetic; Genomics; Goals; Gynecology; High-Risk Pregnancy; Human Resources; Intravenous; Journals; Laboratories; Lasers; Low-Level Laser Therapy; Magnesium Sulfate; Maternal and Child Health; Medical; Medicine; Methods; Mosses; Multicenter Studies; Multicenter Trials; National Institute of Child Health and Human Development; Neonatal; Neonatology; Neurologic; Neurological outcome; New England; Notification; Nuchal Translucency; Nuchal Translucency Measurement; Numbers; Nurse Administrator; Nursing Research; Obstetrics Departments; Outcome; Patient Recruitments; Patients; Performance; Perinatal; Pharmacology; Physician Executives; Placebos; Policies; Population; Pregnancy; Pregnant Women; Premature Birth; Premature Labor; Prenatal Diagnosis; Prenatal care; Procedures; Productivity; Prospective Studies; Proteomics; Protocols documentation; Publications; Purpose; Radiology Specialty; Randomized; Randomized Clinical Trials; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Risk; Safety; Screening procedure; Second Pregnancy Trimester; Site; System; Testing; Texas; Tissues; Twin Multiple Birth; Twin Studies; Ultrasonography; United States; United States National Institutes of Health; Universities; Upper arm; Vagina; Week; Woman; cohort; concept; congenital heart disorder; design; experience; fetal; follow-up; improved; interest; intrapartum; laser photocoagulation; member; preterm premature rupture of membranes; prevent; programs; prospective; response; stillbirth

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.

描述（由申请人提供）：德克萨斯大学医学分支（UTMB）具有积极参与合作多中心MFMU网络所需的要素。主要研究者乔治萨阿德和候补主要研究者加里汉金斯在研究设计、招募、数据分析和几项NIH多中心临床试验的出版物方面拥有丰富的经验（第一和第二孕期非整倍体风险评估，产前硫酸镁研究的有益作用，双胞胎输血综合征试验，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，早产研究的基因组/蛋白质组学网络）。我们通过使用妇产科部门广泛的区域妇幼保健计划（RMCHP）成功地招募/留住患者。RMCHP每年为11 000多名多族裔孕妇提供产前护理。所有RMCHP诊所都遵循母胎医学司制定的协议，所有产前和产时病人都在部门控制之下。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5，000多例高危妊娠，90%以上在我们的系统中接受产前护理。卫生部的电子医疗记录系统收集产前和分娩期间的数据，在线输入，随时可供授权研究人员查询和自动通知。EMR和政策/程序已经成功地调整，以最大限度地提高我们的研究生产力与其他合作网站相比。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。其他关键人员在这个应用程序中，包括加兰安德森，我们的部门以及目前的MFMU网络，珍妮特布兰登，CRD护理主任，和琼莫斯，CRD协调员，带来了丰富的经验和专业知识的团队。PI和候补PI（也是MFM部门主任和RMCHP医疗主任）之间的出色和多产合作为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，在许多领域的相关RFA的专业知识。最后，我们与我们大学的新生儿科，遗传学，围产期病理学，临床实验室和放射学部门建立了良好的合作关系。在各级，UTMB强调一般的研究，与多个核心设施提供给网络，包括GCRC，特别是产科研究（我们的部门排名第9位在美国国立卫生研究院资助全国，1在得克萨斯州）。我们的概念方案比较了产前单疗程与多疗程皮质类固醇的疗效和安全性。我们接受外地住房安排的按人头收费和参与性规定，并随时准备作为该网络的一个富有成效的成员作出贡献。