Dap Matthieu, Chen Bailiang, Banasiak Claire, Hossu Gabriela, Morel Olivier, Beaumont Marine, Bertholdt Charline
Obstetric and Fetal Medicine Unit, Centre Hospitalier Régional Universitaire of Nancy, Nancy, France.
Department of Foetopathology and Placental Pathology, Centre Hospitalier Régional Universitaire of Nancy, Nancy, France.
JMIR Res Protoc. 2022 Aug 10;11(8):e35051. doi: 10.2196/35051.
Preeclampsia (PE) and intrauterine growth restriction (IUGR) are 2 major pregnancy complications due to abnormal placental vasculogenesis. Data on whole fetoplacental vasculature are still missing; hence, these pathologies are not well understood. Ex vivo magnetic resonance imaging (MRI) angiography has been developed to characterize the human placental vasculature by injecting a contrast agent within the umbilical cord.
The primary objective of this study is to compare the placental vascular architecture between normal and pathological pregnancies. This study's secondary objectives are to (1) compare texture features on MRI between groups (normal and pathological), (2) quantitatively compare the vascular architecture between both pathological groups (pathological IUGR, and pathological PE), (3) evaluate the quality of the histological examination in injected placentas, and (4) compare vascularization indices to histological characteristics.
This is a prospective controlled study. We expect to include 100 placentas: 40 from normal pregnancies and 60 from pathological pregnancies (30 for IUGR and 30 for PE). Ex vivo MR image acquisition will be performed shortly after delivery and with preparation by injection of a contrast agent in the umbilical cord. The vascular architecture will be quantitatively described by vascularization indices measured from ex vivo MRI angiography data. Comparisons of vascularization indices and texture features in accordance with the group and within comparable gestational age will be also performed. After MR image acquisition, placental histopathological analysis will be performed.
The enrollment of women began in November 2019. In view of the recruitment capacity of our institution and the availability of the MRI, recruitment should be completed by March 2022. As of November 2021, we enrolled 70% of the intended study population.
This study protocol aims to provide information about the fetal side of placental vascular architecture in normal and pathological placenta through MRI.
Clinicaltrials.gov NCT04389099; https://clinicaltrials.gov/ct2/show/NCT04389099.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35051.
子痫前期（PE）和胎儿生长受限（IUGR）是胎盘血管生成异常导致的两种主要妊娠并发症。关于整个胎儿 - 胎盘血管系统的数据仍然缺失；因此，对这些病症的了解尚不充分。已开发出离体磁共振成像（MRI）血管造影术，通过在脐带内注射造影剂来描绘人类胎盘血管系统。
本研究的主要目的是比较正常妊娠和病理妊娠之间的胎盘血管结构。本研究的次要目的是：（1）比较两组（正常组和病理组）MRI上的纹理特征；（2）定量比较两个病理组（病理性IUGR和病理性PE）之间的血管结构；（3）评估注射造影剂后的胎盘组织学检查质量；（4）比较血管化指数与组织学特征。
这是一项前瞻性对照研究。我们预计纳入100个胎盘：40个来自正常妊娠，60个来自病理妊娠（30个为IUGR，30个为PE）。离体MR图像采集将在分娩后不久进行，并通过在脐带内注射造影剂来准备。血管结构将通过从离体MRI血管造影数据测量的血管化指数进行定量描述。还将根据组以及在可比孕周内比较血管化指数和纹理特征。在MR图像采集后，将进行胎盘组织病理学分析。
女性入组于2019年11月开始。鉴于我们机构的招募能力和MRI的可用性，招募应在2022年3月前完成。截至2021年11月，我们已招募了预期研究人群的70%。
本研究方案旨在通过MRI提供有关正常和病理胎盘的胎盘血管结构胎儿侧的信息。
Clinicaltrials.gov NCT04389099；https://clinicaltrials.gov/ct2/show/NCT04389099。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/35051。
