Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT04212234
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2019-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pregnant Obese Women and Fetal Ultrasound Quality.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Scans will be evaluated by independent experts who had not performed the exams. Scans will be anonymized and ultrasound propagation velocity will not be reported on the images.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 596}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2019-08-30', 'studyFirstSubmitQcDate': '2019-12-24', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'image quality of fetal ultrasound exam', 'timeFrame': 'second trimester and third trimester ultrasound exam', 'description': "Quality will be assessed by calculating Salomon's score for each image."}, {'measure': 'completeness of fetal ultrasound exam', 'timeFrame': 'second trimester and third trimester ultrasound exam', 'description': 'completeness will be assessed by the number of the recommended images which could have been registered during the first ultrasound exam in each trimester.'}], 'secondaryOutcomes': [{'measure': 'use of supplementary ultrasound exams in order to assess completeness', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'description of each modality of supplemental ultrasound exam'}, {'measure': 'description of ultrasonographist method in order to improve ultrasound exam', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'description of modality'}, {'measure': 'economic analysis of the intervention', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'cost-effectiveness analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fetal ultrasound', 'ultrasound propagation velocity', 'image quality', 'obese women'], 'conditions': ['Obese Women', 'Pregnant Women']}, 'referencesModule': {'references': [{'pmid': '34548341', 'type': 'DERIVED', 'citation': 'Delabaere A, Chauveau B, Lemery D, Ollier A, Guiguet-Auclair C, Mourgues C, Legrand A. Protocol for the e-POWUS Project: multicentre blinded-randomised controlled trial of ultrasound speed choice to improve sonography quality in pregnant women with obesity. BMJ Open. 2021 Sep 21;11(9):e038684. doi: 10.1136/bmjopen-2020-038684.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.', 'detailedDescription': 'Obese pregnant women will be included before the second trimester fetal ultrasound examination.\n\nWomen will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.\n\nIn the control group, exam will be performed using the conventional ultrasound velocity.\n\nAn exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.\n\nThe protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.\n\nAll scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index\\>30\n* Between 20 and 25 weeks of gestation\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Uterine scare'}, 'identificationModule': {'nctId': 'NCT04212234', 'acronym': 'EPOWUS', 'briefTitle': 'Pregnant Obese Women and Fetal Ultrasound Quality.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Echography in Pregnant Obese Women and Ultrasound Speed.', 'orgStudyIdInfo': {'id': 'PHRC IR 2018 DELABAERE'}, 'secondaryIdInfos': [{'id': '2018-A03478-47', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'free ultrasound propagation velocity', 'description': 'ultrasound exams will be performed using several ultrasound propagation velocities', 'interventionNames': ['Device: ultrasound propagation velocities, ultrasound fetal quality']}, {'type': 'NO_INTERVENTION', 'label': 'conventional ultrasound propagation velocity', 'description': 'ultrasound exams will be performed using the 1540m/s conventional celerity'}], 'interventions': [{'name': 'ultrasound propagation velocities, ultrasound fetal quality', 'type': 'DEVICE', 'description': 'Obese pregnant women will be included before the second trimester fetal ultrasound examination.\n\nWomen will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.\n\nIn the control group, exam will be performed using the conventional ultrasound velocity.\n\nAn exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.\n\nThe protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.\n\nAll scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al.', 'armGroupLabels': ['free ultrasound propagation velocity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Femme Mére Enfant - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Arnaud de Villeneuve - CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin - Assistance Publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Amélie Delabaere, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}