Cargando…

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”)

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Bertholdt, Charline, Eszto, Marie-Laure, Tournier, Mathilde, Hossu, Gabriela, Mellouki, Naoual, Cherifi, Aboubaker, Morel, Olivier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6747665/
https://www.ncbi.nlm.nih.gov/pubmed/31511289
http://dx.doi.org/10.1136/bmjopen-2019-030353
_version_ 1783451950879080448
author Bertholdt, Charline
Eszto, Marie-Laure
Tournier, Mathilde
Hossu, Gabriela
Mellouki, Naoual
Cherifi, Aboubaker
Morel, Olivier
author_facet Bertholdt, Charline
Eszto, Marie-Laure
Tournier, Mathilde
Hossu, Gabriela
Mellouki, Naoual
Cherifi, Aboubaker
Morel, Olivier
author_sort Bertholdt, Charline
collection PubMed
description 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).
format Online
Article
Text
id pubmed-6747665
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-67476652019-09-27 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”) Bertholdt, Charline Eszto, Marie-Laure Tournier, Mathilde Hossu, Gabriela Mellouki, Naoual Cherifi, Aboubaker Morel, Olivier BMJ Open Obstetrics and Gynaecology 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). BMJ Publishing Group 2019-09-11 /pmc/articles/PMC6747665/ /pubmed/31511289 http://dx.doi.org/10.1136/bmjopen-2019-030353 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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/.
spellingShingle Obstetrics and Gynaecology
Bertholdt, Charline
Eszto, Marie-Laure
Tournier, Mathilde
Hossu, Gabriela
Mellouki, Naoual
Cherifi, Aboubaker
Morel, Olivier
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”)
title 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”)
title_full 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”)
title_fullStr 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”)
title_full_unstemmed 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”)
title_short 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”)
title_sort 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”)
topic Obstetrics and Gynaecology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6747665/
https://www.ncbi.nlm.nih.gov/pubmed/31511289
http://dx.doi.org/10.1136/bmjopen-2019-030353
work_keys_str_mv AT bertholdtcharline assessmentofuteroplacentalvascularisationinearlyfirsttrimesterpregnancywithcontrastenhancedultrasoundand3dpowerdopplerangiographyprotocolforaprospectivecrosssectionalmulticentreandnonrandomisedopenstudyhopestudy
AT esztomarielaure assessmentofuteroplacentalvascularisationinearlyfirsttrimesterpregnancywithcontrastenhancedultrasoundand3dpowerdopplerangiographyprotocolforaprospectivecrosssectionalmulticentreandnonrandomisedopenstudyhopestudy
AT tourniermathilde assessmentofuteroplacentalvascularisationinearlyfirsttrimesterpregnancywithcontrastenhancedultrasoundand3dpowerdopplerangiographyprotocolforaprospectivecrosssectionalmulticentreandnonrandomisedopenstudyhopestudy
AT hossugabriela assessmentofuteroplacentalvascularisationinearlyfirsttrimesterpregnancywithcontrastenhancedultrasoundand3dpowerdopplerangiographyprotocolforaprospectivecrosssectionalmulticentreandnonrandomisedopenstudyhopestudy
AT melloukinaoual assessmentofuteroplacentalvascularisationinearlyfirsttrimesterpregnancywithcontrastenhancedultrasoundand3dpowerdopplerangiographyprotocolforaprospectivecrosssectionalmulticentreandnonrandomisedopenstudyhopestudy
AT cherifiaboubaker assessmentofuteroplacentalvascularisationinearlyfirsttrimesterpregnancywithcontrastenhancedultrasoundand3dpowerdopplerangiographyprotocolforaprospectivecrosssectionalmulticentreandnonrandomisedopenstudyhopestudy
AT morelolivier assessmentofuteroplacentalvascularisationinearlyfirsttrimesterpregnancywithcontrastenhancedultrasoundand3dpowerdopplerangiographyprotocolforaprospectivecrosssectionalmulticentreandnonrandomisedopenstudyhopestudy