Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 3:18 AM
Study NCT ID:
NCT04432805
Status:
TERMINATED
Last Update Posted:
2022-08-12
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'recruitment issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the lesions', 'timeFrame': '4 months', 'description': 'Description of the lesions in each of the 6 pulmonary quadrants on the right and left. Establishment of the ultrasound score corresponding to the sum of the scores attributed to each type of lesion in each quadrant (0: normal, 1: spaced comet tails, 2: curtain comet tails, 3: consolidation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnant Women Suspected of COVID-19']}, 'descriptionModule': {'briefSummary': 'Cohort prospective study.\n\nObjectives :\n\nPrimary objective:\n\nTo describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19\n\nSecondary objectives:\n\n* To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions\n* To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant women\n* To evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed COVID-19\n* To describe the pregnancy issues of the study population\n\nCourse of the study:\n\n* Inclusion of pregnant suspected of having COVID-19 and cared following the service protocol\n* Performing of lung ultrasound at bedside in labor ward or in COVID unit\n\nPrimary outcome:\n\nLung ultrasound lesions (and corresponding score) at the moment of the initial management of pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Gestational age greater than or equal to 22 weeks of gestation\n* Pregnant women suspected of COVID-19 :\n* already having a nasopharyngeal RT-PCR for the SARS-CoV-2\n* AND having a chest CT-scan or waiting for this exam\n* Women giving a writing consent to participate\n\nExclusion Criteria:\n\n* Women giving an opposition to participate\n* Women not enough fluent in French to benefit from clear and intelligible information'}, 'identificationModule': {'nctId': 'NCT04432805', 'acronym': 'LUSCOVIDPREG', 'briefTitle': 'Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19', 'orgStudyIdInfo': {'id': '2020-30'}, 'secondaryIdInfos': [{'id': '2020-A01303-36', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnant women', 'description': 'Pregnant women suspected of COVID-19', 'interventionNames': ['Device: Performing of lung ultrasound']}], 'interventions': [{'name': 'Performing of lung ultrasound', 'type': 'DEVICE', 'description': 'Performing of lung ultrasound at bedside in labor ward or in COVID unit', 'armGroupLabels': ['Pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jean-Olivier ARNAUD, Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}