NICHD Maternal Fetal Medicine Units Network

NICHD 母胎医学单位网络

• 批准号: 7367973
• 负责人: GEORGE R. SAADE
• 金额: $ 78.46万
• 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/7367973
• 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部 (UTMB) 具备积极参与合作多中心 MFMU 网络所需的要素。 PI George Saade 和候补 PI Gary Hankins 在多项 NIH 多中心临床试验（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效果、双胎输血综合征试验、阴道超声环扎试验、死产协作研究）的研究设计、招募、数据分析和出版物方面带来了丰富的经验。 网络、产科-胎儿药理学研究单位网络、早产研究基因组/蛋白质组网络）。我们通过利用妇产科广泛的地区妇幼健康计划 (RMCHP) 成功招募/保留患者。 RMCHP 每年为超过 11,000 名多民族孕妇提供产前护理。所有 RMCHP 诊所均遵循母胎医学部门制定的方案，所有产前和产时患者均处于部门控制之下。我们的临床基础设施和患者群体使我们做好了参与该网络的充分准备，因为我们每年接生 5,000 多例高危妊娠，其中 90% 以上在我们的系统中接受产前护理。该部门的电子病历系统（EMR）采集产前和产中数据，在线输入并随时授权研究人员进行查询和自动通知。与其他合作网站相比，电子病历和政策/程序已成功调整，以最大限度地提高我们的研究生产力。该部门由专门的研究护士和协调员组成的团队（主席研究部 [CRD]）和组织生物库在 PI 的指导下，提高了临床研究的效率。此应用程序中的其他关键人员，包括我们部门和现任 MFMU 网络主席 Garland Anderson、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（同时担任 MFM 部门主任和 RMCHP 医疗主任）之间的出色且多产的合作为网络提供了进一步的好处和功效。我们部门拥有一支富有成效且资金充足的基础科学研究小组，在与 RFA 相关的许多领域拥有专业知识。最后，我们与大学的新生儿科、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。在各个层面上，UTMB 都强调总体研究，网络可使用多个核心设施，包括 GCRC，特别是产科研究（我们部门在 NIH 资助方面在全国排名第 9 位，在德克萨斯州排名第 1 位）。我们的概念方案比较了单疗程与多疗程产前皮质类固醇的功效和安全性。我们接受 RFA 的按人头付费和参与性规定，并随时准备作为网络的富有成效的成员做出贡献。