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Scope and Causes of Stillbirth

Scope and Causes of Stillbirth
死产的范围和原因
批准号:
7106486
负责人:
GEORGE R. SAADE
金额:
$43.52万
依托单位国家:
美国
项目类别:
财政年份:
2003
资助国家:
美国
项目状态:
已结题
起止时间:
2003-09-26 至 2008-07-31

项目摘要

项目成果

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中文摘要
翻译
描述(由申请人提供):德克萨斯大学医学分支加尔维斯顿(UTMB)有能力作为NIH多站点死胎网络的成员积极参与。PI乔治R. Saade博士在几个NIH多地点临床试验中提供了丰富的经验:第一和第二个三个月评估非整倍体风险(FASTER);第一个三个月颈部半透明和先天性心脏病的风险;双胞胎输血综合征试验;和尿道硫酸镁研究(BEAM)的有益作用。我们通过频繁参与UTMB广泛的地区妇幼保健计划(RMCHP),成功招募和留住了患者。RMCHP的所有诊所都遵循母胎医学部门制定的协议,患者在加尔维斯顿的UTMB分娩。UTMB服务的两个县--加尔维斯顿和布拉索里亚--的孕妇将构成基于地理的人口。超过90%的患者在UTMB诊所接受护理,并在John Sealy医院分娩。如果需要,这一目标人群可以根据邮政编码或县酌情扩展到其他RMCHP诊所。此外,卫生部的电子病历记录了产前和产时的信息,并在线输入,可随时供授权调查人员查询。同样,我们部门的组织库为临床研究增加了广泛的效率。PI和Co-I,Radec Bukowski,MD,PhD之间的出色和富有成效的合作为死产网络提供了进一步的好处。此外,我们部门的遗传学顾问,詹妮弗李,谁将作为我们网站的外展工作者,带来了相当丰富的经验,作为一个既定的悲伤顾问。我们的部门有一个非常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,如感染,血管生理学,胎盘功能和胎儿生长。最后,我们与我们大学的病理学系以及遗传学和新生儿学部门建立了良好的合作关系(见支持信)。特别是,UTMB有一个高度重视的围产期病理学部门,在RFA感兴趣的各个领域拥有专业知识,包括神经病理学和胎盘病理学。根据我们目前对DNA微阵列技术的兴趣,我们提出的研究概念是确定死产特定的单核苷酸多态性(SNP)标记谱。我们接受RFA的人头和参与规定,并随时准备成为NIH死胎网络的贡献成员。
英文摘要
DESCRIPTION (provided by applicant): The University of Texas Medical Branch at Galveston (UTMB) has the capability to participate actively as a member of the NIH multisite Stillbirth Network. PI George R. Saade, MD, offers extensive experience within several NIH multisite clinical trials og: First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER); First Trimester Nuchal Translucency and the Risk of Congenital Heart Disease; Twin-Twin Transfusion Syndrome Trial; and Beneficial Effects of Antenatal Magnesium Sulfate Study (BEAM). We have achieved successful patient recruitment and retention by frequent involvement with UTMB's extensive Regional Maternal & Child Health Program (RMCHP). All of RMCHP's clinics follow protocols established by the Maternal-Fetal Medicine division, and the patients are delivered at UTMB in Galveston. Pregnant women in two counties served by UTMB--Galveston and Brazoria--will constitute the geographic-based population. More than 90% of these patients are cared for at a UTMB clinic and deliver at John Sealy Hospital. If needed, this target population can be expanded to other RMCHP clinics based on zip codes or counties, as appropriate. Further, the Department's Electronic Medical Record captures antepartum and intrapartum information, entered on-line, that is readily available for query by authorized investigators. In like manner, our Department's Tissue Bank has added broad efficiencies to clinical investigation. The excellent and productive collaboration between PI and Co-I, Radec Bukowski, MD, PhD, offers further benefits to the Stillbirth Network. In addition, our Department's genetics counselor, Jennifer Lee, who will serve as our site's outreach worker, brings considerable experience as an established grief counselor. Our Department has a very productive and well-funded basic science research group with expertise in many areas of relevance to the RFA, such as infection, vascular physiology, placental function, and fetal growth. Finally, we have well-established collaborative ties with our University's Department of Pathology and divisions of Genetics and Neonatology (see letters of support). In particular, UTMB has a highly regarded Perinatal Pathology division with expertise in various areas of interest to this RFA, including neuropathology and placental pathology. Following on our current interest in DNA microarray technology, our proposed study concept is to determine a single nucleotide polymorphism (SNP) marker profile particular to stillbirth. We accept the capitation and participatory stipulations of this RFA and stand ready to become a contributinq member of the NIH Stillbirth Network.
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