Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

未产妇早产：未充分研究的高危人群

基本信息

批准号：
7790992
负责人：
SAMUEL I. PARRY
金额：
$ 20.74万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-01-10 至 2012-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7790992
关键词：
Affect Angiogenic Factor Arteries Biological Assay Biological Markers Cells Cervical Clinical Clinical Research Cohort Studies Collaborations Consultations Data Data Quality Discipline of obstetrics Enrollment Environmental Exposure Functional disorder Genetic Genomics Gynecology Health system Histology Hospitals Label Laboratory Study Length Neonatal Mortality Outcome Participant Patient Recruitments Pennsylvania Physicians Population Population Study Pregnancy Premature Birth Principal Investigator Proteins Proteomics Protocols documentation Publications Research Research Design Research Personnel Risk Risk Factors Sample Size Sampling Studies Services Site Techniques Testing Translational Research Ultrasonography Universities University Hospitals Woman design fetal medicine high throughput screening interest novel therapeutics prenatal prevent prospective public health relevance sample collection transcriptomics

项目摘要

DESCRIPTION (provided by applicant): The University of Pennsylvania Health System's Department of Obstetrics and Gynecology reflects a long tradition of excellence in clinical and translational research. Investigators within the Division of Maternal-Fetal Medicine have been key participants in this tradition, particularly in their studies of genetic factors and environmental exposures that are associated with preterm birth. In this application, we provide information on the two hospitals that comprise the obstetric services at the University of Pennsylvania - the Hospital of the University of Pennsylvania (HUP) and Pennsylvania Hospital (PAH) - both of which are proposed sites of patient recruitment for the network. The specific aims of this application are: 1) to provide consultation on the design of network studies, which includes assisting the Steering Committee in study design, sample size calculations, and statistical analyses, and selecting optimal data and sample collection protocols; 2) to enroll subjects into network studies and to provide quality data for network studies; 3) to perform ultrasound studies, laboratory assays, and high-throughput genomics and proteomics assays required to complete proposed studies; and 4) to be involved in the analysis and publication of network studies. The combined delivery volume of HUP and PAH is over 9,000 per year. The MFM physicians at the two hospitals share clinical responsibilities and have a substantial track record for collaboration in various clinical studies. Importantly, the principal investigator for this application is the principal investigator of the Analytical Core for the Genomics and Proteomics Network for Preterm Birth Research and will bring significant expertise regarding study design, sample collection, and assay techniques (including high-throughput studies), to the proposed preterm birth network. The investigators propose a prospective cohort study in which prenatal ultrasound findings (cervical length, uterine artery Doppler flow), protein biomarkers (circulating angiogenic factors, proteomics techniques using labeled proteins from cells of interest), and transcriptomics assays will be correlated with clinical outcomes and placental histology findings. The hypothesis to be tested is that markers of placental dysfunction early in pregnancy will identify nulliparous women at risk of preterm birth. PUBLIC HEALTH RELEVANCE: Preterm birth affects 12 percent of all pregnancies in the U.S., and complications from preterm delivery are the second leading cause of neonatal mortality. Nulliparous women are an under-studied population, particularly concerning their risk of preterm birth. The proposed network to study preterm birth in nulliparous women has the opportunity to identify risk factors for preterm birth among these women and develop novel therapeutic strategies to prevent preterm deliveries.

描述（由申请人提供）：宾夕法尼亚大学卫生系统的妇产科和妇科系反映了临床和转化研究方面卓越的悠久传统。孕产妇医学划分的研究人员是这一传统的关键参与者，尤其是在对与早产相关的遗传因素和环境暴露的研究中。在此应用程序中，我们提供了有关宾夕法尼亚大学（宾夕法尼亚大学医院（HUP）和宾夕法尼亚州医院（PAH）的两家医院的信息，这些医院均提出了该网络的患者招募。该应用程序的具体目的是：1）提供有关网络研究设计的咨询，其中包括协助指导委员会进行研究设计，样本量计算和统计分析，并选择最佳数据和样本收集协议； 2）将受试者纳入网络研究并为网络研究提供质量数据； 3）进行超声研究，实验室测定以及完成建议的研究所需的高通量基因组学和蛋白质组学测定； 4）参与网络研究的分析和发布。 HUP和PAH的综合交付量每年超过9,000。两家医院的MFM医生负责临床责任，并在各种临床研究中合作有巨大的记录。重要的是，该应用的主要研究者是早产研究基因组学和蛋白质组学网络的分析核心的主要研究者，并将为拟议的早产网络带来有关研究设计，样本收集和测定技术的重要专业知识（包括高通量研究）。研究人员提出了一项前瞻性队列研究，其中蛋白质生物标志物（循环血管生成因子，使用兴趣细胞的标记蛋白质蛋白质学技术）和转录组学评估将与临床学途径相吻合。要检验的假设是，妊娠早期胎盘功能障碍的标志将确定有未来出生风险的无效妇女。公共卫生相关性：早产会影响美国所有怀孕的12％，早产的并发症是新生儿死亡率的第二主要原因。无效的妇女是一个研究不足的人口，特别是关于她们早产的风险。拟议的网络研究无效妇女的早产，有机会确定这些妇女中早产的危险因素，并制定新的治疗策略以防止早产。