Mottet Nicolas, Aubry Sébastien, Vidal Chrystelle, Boiteux Guillaume, Metz Jean-Patrick, Riethmuller Didier, Pazart Lionel, Ramanah Rajeev
Department of Obstetrics and Gynaecology, Pôle Mère-Femme, University Hospital of Besancon, University of Franche-Comte, Besançon, France.
Nanomedecine Laboratory, INSERM EA4662, University of Franche-Comte, Besancon, France.
BMJ Open. 2017 Dec 26;7(12):e018130. doi: 10.1136/bmjopen-2017-018130.
2-D ultrasound shear wave elastography (SWE) could be considered as a new noninvasive tool for monitoring fetal lung development based on evaluation of mechanical properties during pregnancy. Interesting results are available concerning the use of SWE on developing organs, especially on premature infants and animal models. The main objective in this study is to evaluate the feasibility of 2-D SWE in human fetal lungs between 24 and 34 weeks of gestation (WG). The secondary objective is to modellise fetal lung-to-liver elastography ratio (LLE ratio) and to assess variations between normal lung and lung surfactant-enriched after a corticosteroids course indicated for a threatened preterm labour (TPL).
METHODS/DESIGN: A prospective case-control study will be performed between 24 and 34 WG. Fetal lungs and liver will be explored by SWE into two groups: fetuses of women with an uncomplicated pregnancy (control group) and fetuses of women with a TPL requiring administration of corticosteroids (cases group). LLE ratio will be defined as the value of the lung elasticity divided by the value of the liver elasticity.Primary judgement criterion is the value of elasticity modulus expressed in kilopascal. Lungs and liver will be explored through three measurements to define the most reproducible regions with the lowest intra- and inter-observer variability. Feasibility will be evaluated by assessing the number of examinations performed and the number of examinations with interpretable results. Intra- and inter-observer reproducibility will be evaluated by means of the intra-class correlation coefficient.
Approval of the study protocol was obtained from the human ethical research committee (Comité de Protection des Personnes EST II, process number 15/494) and the French National Agency for Medicines and Health Products Safety (process number 2015-A01575-44). All participants will sign a statement of informed consent.
NCT02870608; Recruiting.
二维超声剪切波弹性成像（SWE）可被视为一种基于孕期机械性能评估来监测胎儿肺发育的新型无创工具。关于SWE在发育中器官的应用，尤其是在早产儿和动物模型方面，已有一些有趣的研究结果。本研究的主要目的是评估二维SWE在孕24至34周（WG）的人类胎儿肺中的可行性。次要目的是建立胎儿肺与肝弹性成像比值（LLE比值）模型，并评估在因先兆早产（TPL）而接受皮质类固醇治疗后，正常肺与富含肺表面活性物质的肺之间的差异。
方法/设计：将在24至34周WG期间进行一项前瞻性病例对照研究。通过SWE对胎儿肺和肝进行检查，分为两组：妊娠情况正常的女性所怀胎儿（对照组）和因TPL需要接受皮质类固醇治疗的女性所怀胎儿（病例组）。LLE比值定义为肺弹性值除以肝弹性值。主要判断标准是以千帕为单位表示的弹性模量值。将通过三次测量对肺和肝进行检查，以确定观察者内和观察者间变异性最低且最具可重复性的区域。将通过评估所进行检查的数量以及具有可解释结果的检查数量来评估可行性。将通过组内相关系数评估观察者内和观察者间的可重复性。
本研究方案已获得人类伦理研究委员会（东部第二地区人体保护委员会，流程编号15/494）和法国国家药品与健康产品安全局（流程编号2015 - A01575 - 44）的批准。所有参与者都将签署知情同意书。
NCT02870608；正在招募。
