Novel Tools for the Noninvasive Evaluation of the Human Placenta

用于人类胎盘无创评估的新工具

• 批准号: 9145758
• 负责人: Alfred Z Abuhamad
• 金额: $ 68.14万
• 依托单位: EASTERN VIRGINIA MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-17 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145758
• 关键词: Algorithms; Americas; Biometry; Biopsy; Blood Vessels; Breast Microcalcification; Cardiovascular system; Child; Clinical Research; Collaborations; Color; Control Groups; Data; Development; Discipline of obstetrics; Early identification; Ensure; Evaluation; Fetal Growth Retardation; Fetus; Fibrinogen; Functional disorder; Future; Goals; Health; Human; Image; Imagery; Industry; Leadership; Letters; Measurement; Medical; Methods; Microscopic; Morphologic artifacts; Mothers; Motion; Nomograms; Organ; Outcome; Outcome Study; Pathologic; Pathology; Performance; Perfusion; Placenta; Placentation; Play; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Prenatal care; Prevention; Research Design; Resolution; Risk; Risk Factors; Role; Structure; System; Technical Expertise; Techniques; Technology; Testing; Time; Tissues; Translational Research; Ultrasonography; Vascular remodeling; Woman; adverse outcome; adverse pregnancy outcome; at-risk pregnancies; base; body system; cohort; design; elastography; fetal; high risk; image processing; imaging modality; improved; improved outcome; in vivo; indexing; longitudinal design; neonatal outcome; novel; prevent; primary outcome; research and development; soft tissue; technology development; tool; transcriptome

 DESCRIPTION (provided by applicant): Mounting evidence suggests that abnormal placental development in early gestation is highly associated with many maternal and fetal pathologic conditions, which can manifest later in pregnancy. The ability to evaluate in real time human placental structure and function in early gestation by using novel ultrasound tools will allow for the identification of early markers of placental dysfunction with the ultimate long- term goal of prevention of adverse pregnancy outcomes. As initial steps in accomplishing this long-term goal, we propose this study designed to find which of the novel ultrasound tools are best at discriminating between women who will develop adverse pregnancy outcomes and those who will not. We have formed collaboration with Toshiba Medical Systems, one of the ultrasound industry leaders, that is focused on evaluating recently developed novel ultrasound tools that substantially expand our ability to study placental structure and function in vivo. This collaboration will advance the field through technology development and translational research. Our collaboration brings together novel tools, strong technological expertise, leadership in obstetrical ultrasound, and a track record of clinical research. The novel ultrasound tools that will be used in our study include Superb Micro-Vascular Imaging (SMI) for the comprehensive assessment of placental microvasculature, Shear Wave Elastography (SWE) for the evaluation of placental tissue stiffness and MicroPure(r) for the visualization of placental microcalcificatios content. We plan to apply these novel ultrasound tools, along with fetal and placental biometric and 3D ultrasound measurements, on a control group of normal pregnancies and a study group of at-risk pregnancies starting from early gestation and in a longitudinal cohort design. Maternal and neonatal outcome will be collected along with storage of biospecimen and placental pathology for future evaluation. Pregnancy ending at less than 37 0/7 weeks' gestation for any cause will be the primary study outcome and will differentiate normal from abnormal pregnancy. The ultrasound data will be analyzed to identify significant early markers of placental dysfunction. We have 3 study aims. First is to develop longitudinal nomograms for the novel ultrasound tools in normal human pregnancies. Second is to apply these novel ultrasound tools to study placental development in at-risk human pregnancies. Third to develop and evaluate an overall novel placental ultrasound marker: "The Placental Index" as an early gestation, non-invasive, marker of placental dysfunction for the prediction of adverse human pregnancy outcomes.

 描述（由申请人提供）：越来越多的证据表明，妊娠早期胎盘发育异常与许多母体和胎儿病理状况高度相关，这些病理状况可能在妊娠后期表现出来。通过使用新的超声工具在妊娠早期真实的时间评估人类胎盘结构和功能的能力将允许识别胎盘功能障碍的早期标志物，最终的长期目标是预防不良妊娠结局。作为实现这一长期目标的初步步骤，我们提出这项研究旨在发现哪些新型超声工具最能区分哪些女性会出现不良妊娠结局，哪些不会。我们已经与超声波行业领导者之一的东芝医疗系统公司建立了合作关系，该公司专注于评估最近开发的新型超声波工具，这些工具大大扩展了我们在体内研究胎盘结构和功能的能力。这项合作将通过技术开发和转化研究推进该领域。我们的合作汇集了新颖的工具，强大的技术专长，在产科超声的领导地位，以及临床研究的跟踪记录。本研究中使用的新型超声工具包括用于全面评估胎盘微血管的Superb Micro-Vascular Imaging（SMI）、用于评估胎盘组织硬度的剪切波弹性成像（SWE）和用于可视化胎盘微钙化内容的MicroPure（r）。我们计划应用这些新的超声工具，沿着胎儿和胎盘的生物统计学和3D超声测量，在正常妊娠的对照组和从妊娠早期开始的高危妊娠的研究组中，并在纵向队列设计中。将沿着收集母体和新生儿结局，并储存生物标本和胎盘病理学，以供将来评价。任何原因导致的妊娠在妊娠37 0/7周内结束将是主要研究结局，并将区分正常妊娠和异常妊娠。将分析超声数据以确定胎盘功能障碍的重要早期标志物。我们有三个学习目标。首先是开发纵向诺模图的新的超声工具在正常人怀孕。第二是应用这些新的超声工具来研究高危妊娠中的胎盘发育。第三，开发和评估一种全新的胎盘超声标记物：“胎盘指数”，作为妊娠早期、非侵入性的胎盘功能障碍标记物，用于预测人类不良妊娠结局。