Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study
Context Variability in 2D ultrasound (US) is related to the acquisition of planes of reference and the positioning of callipers and could be reduced in combining US volume acquisitions and anatomical structures recognition.Objectives The primary objective is to assess the consistency between 3D meas...
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| Format: | Article |
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BMJ Publishing Group
2019-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/12/e031777.full |
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| author | Marine Beaumont Olivier Morel Gabriela Hossu Gaëlle Ambroise Grandjean Claire Banasiak Cybele Ciofolo-Veit Caroline Raynaud Laurence Rouet |
| author_facet | Marine Beaumont Olivier Morel Gabriela Hossu Gaëlle Ambroise Grandjean Claire Banasiak Cybele Ciofolo-Veit Caroline Raynaud Laurence Rouet |
| author_sort | Marine Beaumont |
| collection | DOAJ |
| description | Context Variability in 2D ultrasound (US) is related to the acquisition of planes of reference and the positioning of callipers and could be reduced in combining US volume acquisitions and anatomical structures recognition.Objectives The primary objective is to assess the consistency between 3D measurements (automated and manual) extracted from a fetal US volume with standard 2D US measurements (I). Secondary objectives are to evaluate the feasibility of the use of software to obtain automated measurements of the fetal head, abdomen and femur from US acquisitions (II) and to assess the impact of automation on intraobserver and interobserver reproducibility (III).Methods and analysis 225 fetuses will be measured at 16–30 weeks of gestation. For each fetus, six volumes (two for head, abdomen and thigh, respectively) will be prospectively acquired after performing standard 2D biometry measurements (head and abdominal circumference, femoral length). Each volume will be processed later by both a software and an operator to extract the reference planes and to perform the corresponding measurements. The different sets of measurements will be compared using Bland-Altman plots to assess the agreement between the different processes (I). The feasibility of using the software in clinical practice will be assessed through the failure rate of processing and the score of quality of measurements (II). Interclass correlation coefficients will be used to evaluate the intraobserver and interobserver reproducibility (III).Ethics and dissemination The study and related consent forms were approved by an institutional review board (CPP SUD-EST 3) on 2 October 2018, under reference number 2018–033 B. The study has been registered in https://clinicaltrials.gov registry on 23 January 2019, under the number NCT03812471. This study will enable an improved understanding and dissemination of the potential benefits of 3D automated measurements and is a prerequisite for the design of intention to treat randomised studies assessing their impact.Trial registration number NCT03812471; Pre-results. |
| format | Article |
| id | doaj-art-70399b4e2bee4fc39f611ad6ca96eb05 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-70399b4e2bee4fc39f611ad6ca96eb052025-08-20T02:51:00ZengBMJ Publishing GroupBMJ Open2044-60552019-12-0191210.1136/bmjopen-2019-031777Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional studyMarine Beaumont0Olivier Morel1Gabriela Hossu2Gaëlle Ambroise Grandjean3Claire Banasiak4Cybele Ciofolo-Veit5Caroline Raynaud6Laurence Rouet7CIC-Innovation Technologique, CHRU Nancy, Vandoeuvre-lès-Nancy, Lorraine, FranceInserm IADI, Université de Lorraine, Nancy, FranceInserm IADI, Université de Lorraine, Nancy, France1 Obstetrics Department, CHRU Nancy, Nancy, Lorraine, FranceInserm, CIC Innovation Technologique, CHRU-Nancy, Nancy, France5 Philips Research France, Suresnes, France5 Philips Research France, Suresnes, France5 Philips Research France, Suresnes, FranceContext Variability in 2D ultrasound (US) is related to the acquisition of planes of reference and the positioning of callipers and could be reduced in combining US volume acquisitions and anatomical structures recognition.Objectives The primary objective is to assess the consistency between 3D measurements (automated and manual) extracted from a fetal US volume with standard 2D US measurements (I). Secondary objectives are to evaluate the feasibility of the use of software to obtain automated measurements of the fetal head, abdomen and femur from US acquisitions (II) and to assess the impact of automation on intraobserver and interobserver reproducibility (III).Methods and analysis 225 fetuses will be measured at 16–30 weeks of gestation. For each fetus, six volumes (two for head, abdomen and thigh, respectively) will be prospectively acquired after performing standard 2D biometry measurements (head and abdominal circumference, femoral length). Each volume will be processed later by both a software and an operator to extract the reference planes and to perform the corresponding measurements. The different sets of measurements will be compared using Bland-Altman plots to assess the agreement between the different processes (I). The feasibility of using the software in clinical practice will be assessed through the failure rate of processing and the score of quality of measurements (II). Interclass correlation coefficients will be used to evaluate the intraobserver and interobserver reproducibility (III).Ethics and dissemination The study and related consent forms were approved by an institutional review board (CPP SUD-EST 3) on 2 October 2018, under reference number 2018–033 B. The study has been registered in https://clinicaltrials.gov registry on 23 January 2019, under the number NCT03812471. This study will enable an improved understanding and dissemination of the potential benefits of 3D automated measurements and is a prerequisite for the design of intention to treat randomised studies assessing their impact.Trial registration number NCT03812471; Pre-results.https://bmjopen.bmj.com/content/9/12/e031777.full |
| spellingShingle | Marine Beaumont Olivier Morel Gabriela Hossu Gaëlle Ambroise Grandjean Claire Banasiak Cybele Ciofolo-Veit Caroline Raynaud Laurence Rouet Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study BMJ Open |
| title | Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study |
| title_full | Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study |
| title_fullStr | Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study |
| title_full_unstemmed | Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study |
| title_short | Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study |
| title_sort | optimization of fetal biometry with 3d ultrasound and image recognition epicea protocol for a prospective cross sectional study |
| url | https://bmjopen.bmj.com/content/9/12/e031777.full |
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