Protocol for the e-POWUS Project: multicentre blinded-randomised controlled trial of ultrasound speed choice to improve sonography quality in pregnant women with obesity

Abstract

IntroductionDuring pregnancy, maternal obesity increases the risk of fetal abnormalities. Despite advances in ultrasound imaging, the assessment of fetal anatomy is less thorough among these women. Currently, the construction of ultrasound images uses a conventional ultrasound propagation velocity (1540 m/s), which does not correspond to the slower speed of propagation in fat tissue.The main objective of this randomised study is to compare the completeness of fetal ultrasonography according to whether the operator could choose the ultrasound velocity (1420, 1480 or 1540 m/s) or was required to apply the 1540 m/s velocity.Methods and analysisThis randomised trial is an impact study to compare a diagnostic innovation with the reference technique. The trial inclusion criteria require that a pregnant woman with obesity be undergoing a fetal morphology examination by ultrasound from 20+0 to 25+0 gestational weeks.Randomisation will allocate women into two groups. The first will be the ‘modulable speed’ group, in which operators can choose the speed of ultrasound propagation to be considered for the morphological analysis: 1420, 1480 or 1540 m/s. In the second ‘conventional speed’ group, operators will perform the morphological examination with the ultrasound speed fixed at 1540 m/s. The adjudication committee, two independent experts, will validate the completeness of each examination and the quality of the images.Ethics and disseminationThis research protocol does not change the standard management. The only possible impact is an improvement of the ultrasound examination by improving the quality of the image and the completeness of morphological examination. The Agence du Médicament et produits de santé approved this study (2018-A03478-47). The anonymised data will be available on request from the principal investigator. Results will be reported in peer-reviewed journals and at scientific meetings.Trial registration numberClinicalTrials.gov (http://www.clinicaltrials.gov) Registry (NCT04212234).