Maternal Fetal Medicine Units Network

母胎医学单位网络

• 批准号: 8081491
• 负责人: GEORGE R. SAADE
• 金额: $ 30.6万
• 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 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8081491
• 关键词: Acute; Address; Adherence; Admission activity; Ambulatory Care Facilities; Antioxidants; Area; Award; Basic Science; Beds; Birth; Caring; Cephalic; Cervix Uteri; Clinic; Clinical; Clinical Pathology; Clinical Research; Clinical Services; Clinical Trials; Collaborations; Commit; Communities; Competitive Bidding; Computerized Medical Record; Consent; Core Facility; County; Critical Care; Data; Data Analyses; Data Collection; Data Quality; Development; Diagnostic; Discipline of obstetrics; Documentation; Employee; Enrollment; Equipoise; Evaluation; Evidence based practice; Faculty; Funding; Genetic; Genomics; Gestational Diabetes; Goals; Health; High-Risk Pregnancy; Home environment; Hospitals; Human Resources; Individual; Indomethacin; Information Systems; Informed Consent; Inpatients; Institutes; Institution; Investigation; Laboratories; Lead; Leadership; Letters; Life; Link; Logistics; Low Birth Weight Infant; Magnesium Sulfate; Maternal and Child Health; Medical; Mission; Mosses; Multicenter Trials; National Institute of Child Health and Human Development; Neonatal; Neonatal Intensive Care Units; Neonatology; Network-based; Neurologic; Neurologist; Nifedipine; Notification; Nursing Research; Occupational Therapist; Ophthalmologist; Outcome; Outpatients; Pathology; Patient Care; Patient Recruitments; Patient Rights; Patients; Pediatrics; Perinatal; Persons; Pharmacology; Pharmacy facility; Physician Executives; Policies; Population; Population Study; Positioning Attribute; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Premature Labor; Prenatal Diagnosis; Prenatal care; Prevention; Principal Investigator; Procedures; Productivity; Proteomics; Protocols documentation; Public Health; Publications; Radiology Specialty; Randomized; Randomized Clinical Trials; Recruitment Activity; Research; Research Design; Research Infrastructure; Research Personnel; Screening procedure; Services; Site; Spontaneous abortion; System; Texas; Time; Tissues; Tocolysis; Translational Research; U-Series Cooperative Agreements; Ultrasonography; United States National Institutes of Health; Universities; Visit; Woman; biobank; clinical infrastructure; clinical practice; design; experience; fetal; fetal medicine; follow-up; high risk; improved; innovation; intrapartum; medical schools; member; premature; prenatal; prevent; programs; protocol violation; randomized trial; sample collection; stillbirth; treatment trial

DESCRIPTION (provided by applicant): During our first cycle in the MFMU Network, we demonstrated the ability of our clinical and research infrastructure at The University of Texas Medical Branch (UTMB) to effectively contribute to multisite trials. In addition to productivity in the MFMU Network, the PI, George Saade, and alternate PI, Gary Hankins, bring extensive experience in study design, recruitment, data analysis, and publications from several non-MFMU Networks, such as the Stillbirth Collaborative Research Network, Obstetric Pharmacology Research Units Network, and Genomic/Proteomic Network for Premature Birth Research. We achieved successful patient recruitment and retention through our Department's Regional Maternal & Child Health Program (RMCHP). RMCHP clinics, following protocols set by the Maternal-Fetal Medicine Division, provided prenatal care for more than 12,000 multiethnic pregnant women in 2009. We deliver over 5,000 high-risk pregnancies a year, with more than 90% receiving prenatal care in our system. The Department's Electronic Medical Record System (EMR) captures antepartum and intrapartum data online and is readily available to authorized research personnel for query as well as automatic notification. The EMR and policies/procedures have been successfully adapted to maximize our research productivity. The MFM Division, Tissue BioBank, and team of dedicated research staff in the Perinatal Research Division (PRD), all under the direction of the PI, have broadened efficiency in clinical investigations. Joan Moss, MFMU Research Nurse Coordinator, brings extensive experience and expertise to the team. The prolific collaboration between PI and alternate PI, who is also Department Chair and RMCHP Medical Director, offers further benefit and efficacy to the Network. As the chief of OB, the PI directs the medical management of all Obstetrical patients at UTMB. Our Department has a 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 Institute of Translational Research, the home for UTMB's CTSA. Our Department is consistently one of the top NIH- funded Ob/Gyn departments in the nation. In our concept protocol, we propose to compare the neonatal outcomes following acute tocolysis with nifedipine vs. indomethacin. We accept the RFA's capitation and participatory stipulations and stand ready to continue as productive members of the Network. PUBLIC HEALTH RELEVANCE: Investigations by the MFMU Network focus on problems in clinical obstetrics, particularly those related to prevention of low birth weight, prematurity, and medical problems of pregnancy. These complications can lead to health problems at birth as well as later in life; therefore, research that may lead to their prevention has powerful potential for improving individual lives and public health.

描述（由申请人提供）：在 MFMU 网络的第一个周期中，我们展示了德克萨斯大学医学分部 (UTMB) 的临床和研究基础设施有效促进多站点试验的能力。除了 MFMU 网络的生产力之外，PI George Saade 和候补 PI Gary Hankins 还带来了来自多个非 MFMU 网络（例如死产协作研究网络、产科药理学研究单位网络和早产研究基因组/蛋白质组网络）的研究设计、招募、数据分析和出版物方面的丰富经验。我们通过我们部门的地区妇幼健康计划 (RMCHP) 成功招募和保留患者。 RMCHP 诊所按照母胎医学部门制定的方案，2009 年为超过 12,000 名多民族孕妇提供产前护理。我们每年接生 5,000 多名高危妊娠，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）在线采集产前和产时数据，可供授权研究人员查询和自动通知。 EMR 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。 MFM 部门、组织生物库以及围产期研究部门 (PRD) 的专门研究人员团队在 PI 的指导下，提高了临床研究的效率。 MFMU 研究护士协调员 Joan Moss 为团队带来了丰富的经验和专业知识。 PI 和候补 PI（同时担任系主任和 RMCHP 医疗主任）之间的多产合作为网络提供了进一步的好处和功效。作为产科主任，PI 指导 UTMB 所有产科患者的医疗管理。我们部门拥有一支资金雄厚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，为网络提供多个核心设施，包括转化研究所，UTMB 的 CTSA 所在地。我们的科室一直是美国 NIH 资助的顶级妇产科科室之一。在我们的概念方案中，我们建议比较硝苯地平与吲哚美辛急性安胎后的新生儿结局。我们接受 RFA 的按人头付费和参与性规定，并准备继续作为该网络的富有成效的成员。 公共卫生相关性：MFMU 网络的调查重点是临床产科问题，特别是与预防低出生体重、早产和妊娠医疗问题相关的问题。这些并发症可能会导致出生时和以后的健康问题；因此，可能导致预防的研究对于改善个人生活和公共健康具有巨大潜力。