Article Text

Download PDFPDF

Assessment of uteroplacental vascularisation in early first-trimester pregnancy with contrast-enhanced ultrasound and 3D power Doppler angiography: protocol for a prospective, cross-sectional, multicentre and non-randomised open study (“HOPE Study”)
  1. Charline Bertholdt1,2,
  2. Marie-Laure Eszto3,
  3. Mathilde Tournier1,
  4. Gabriela Hossu2,4,
  5. Naoual Mellouki5,
  6. Aboubaker Cherifi4,
  7. Olivier Morel1,2
  1. 1Obstetric and Fetal Medicine Unit, Maternite Regionale Adolphe Pinard de Nancy, Nancy, France
  2. 2Université de Lorraine, INSERM U1254, IADI, CHU Nancy, Nancy, France
  3. 3Obstetric Department, Metz-Thionville Regional Hospital Center, Mercy Hospital, CHR Metz-Thionville, Metz, France
  4. 4CHRU-Nancy, Inserm, Université de Lorraine, CIC, Innovation Technologique, 54 000, CHU Nancy, NANCY, France
  5. 5Clinical Research Support Unit, Metz-Thionville Regional Hospital Center, Mercy Hospital, CHR Metz-Thionville, Metz, France
  1. Correspondence to Dr Charline Bertholdt; charline.bertholdt{at}gmail.com

Abstract

Introduction Knowledge about the mechanisms leading to the establishment of uteroplacental vascularisation is inadequate, and some of what has been thought to be known for decades has recently been challenged by showing that the intervillous space, the major area of maternal-fetal exchange, appears to be perfused by maternal blood at as early as 6 weeks of gestation. The vascular flow then seems relatively constant until 13 weeks when it appears to increase suddenly.

Objectives The principal objective is to quantify the perfusion of the intervillous space by contrast-enhanced ultrasonography (CEUS) during the first-trimester at three different gestational ages (8, 11 and 13 weeks). The secondary objectives are to: (1) describe the indicators of vascularisation of the placenta (intervillous space) and the myometrium at the three gestational ages, measured by CEUS and three-dimensional power Doppler (3DPD) angiography; (2) compare the diagnostic performance of CEUS and 3DPD for the demonstration and quantification of uteroplacental vascularisation and (3) establish a biological collection of placentas to increase knowledge about placental development and functions during pregnancy.

Methods and analysis This is a prospective, cross-sectional, multicentre and non-randomised open study. We will include 42 women with ongoing pregnancy and divided into three groups of gestational ages (ie, 14 women by per group): 8, 11 and 13 weeks of gestation. 3DPD and then CEUS will be performed and the data about the perfusion kinetics and the 3DPD indices will be calculated and then compared with each other and for each gestational age.

Ethics and dissemination The appropriate French Ethics Committee Est III approved this study and the related consent forms on 5 April 2016, and the competent authority (Agence Nationale de Sécurité du Médicament et des Produits de Santé) authorised the study on 21 June 2016. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.

Trial registration numbers ClinicalTrials.gov registry (NCT02884297); EudraCT registry (2015-005655-27).

  • ultrasonography
  • prenatal diagnosis
  • ultrasound
  • physiology
  • pathology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

View Full Text

Statistics from Altmetric.com

Footnotes

  • Contributors CB, M-LE and OM designed the study and are the principal investigators; AC and NM are project managers; CB wrote the manuscript; CB and MT will carry out recruitment, ultrasound acquisition, placental analysis and will collect the data; GH is in charge of statistical analysis and all authors reviewed and contributed to the manuscript. All authors have read, approved the paper and meet the criteria for authorship as established by the International Committee of Medical Journals Editors.

  • Funding This study won the regional award for clinical research (2016).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval ANSM (the French National Agency for Medicines and Health Products Safety) and the Committee for the Protection of Persons (Comité de Protection des Personnes, CPP) approved this study.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.