Novel Tools for the Noninvasive Evaluation of the Human Placenta

 描述(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亲和胎儿的病理状况高度相关，这些疾病可以在怀孕后期表现出来。通过使用新的超声工具实时评估人类早期妊娠的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记，最终达到防止不良妊娠结局的长期目标。作为实现这一长期目标的第一步，我们建议进行这项研究，旨在找出哪些新型超声工具在区分将出现不良妊娠结局的妇女和那些不会出现不良妊娠结局的妇女方面最好。我们与超声波行业领先者之一东芝医疗系统公司建立了合作关系，专注于评估最近开发的新型超声波工具，这些工具极大地扩展了我们在活体内研究胎盘结构和功能的能力。这种合作将通过技术开发和翻译研究推动该领域的发展。我们的合作将新的工具、强大的技术专业知识、产科超声领域的领先地位以及临床研究的跟踪记录结合在一起。将在我们的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-Vculate成像(SMI)、用于评估胎盘组织硬度的剪切波弹性成像(SWE)和用于显示胎盘微钙化含量的MicroPure(R)。我们计划将这些新的超声工具与胎儿和胎盘的生物测量和三维超声测量一起应用于正常妊娠的对照组和从早期妊娠开始的高危妊娠的研究组，并采用纵向队列设计。孕妇和新生儿的结局将与储存的生物素和胎盘病理一起收集，以供未来评估。无论何种原因，妊娠终止于妊娠370/7周以下将是主要的研究结果，并将区分正常和异常妊娠。将对超声数据进行分析，以确定胎盘功能障碍的重要早期标志。我们有三个研究目标。首先是开发用于正常人类妊娠的新型超声工具的纵向诺模图。第二是应用这些新的超声工具来研究高危人类妊娠的胎盘发育。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、胎盘功能障碍的标记物，用于预测不良的人类妊娠结局。

 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.