Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
NCT ID: NCT04432805
Last Updated: 2022-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2020-10-13
2021-01-02
Brief Summary
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Objectives :
Primary objective:
To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19
Secondary objectives:
* To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions
* To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant women
* To evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed COVID-19
* To describe the pregnancy issues of the study population
Course of the study:
* Inclusion of pregnant suspected of having COVID-19 and cared following the service protocol
* Performing of lung ultrasound at bedside in labor ward or in COVID unit
Primary outcome:
Lung 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)
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Pregnant women
Pregnant women suspected of COVID-19
Performing of lung ultrasound
Performing of lung ultrasound at bedside in labor ward or in COVID unit
Interventions
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Performing of lung ultrasound
Performing of lung ultrasound at bedside in labor ward or in COVID unit
Eligibility Criteria
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Inclusion Criteria
* Gestational age greater than or equal to 22 weeks of gestation
* Pregnant women suspected of COVID-19 :
* already having a nasopharyngeal RT-PCR for the SARS-CoV-2
* AND having a chest CT-scan or waiting for this exam
* Women giving a writing consent to participate
Exclusion Criteria
* Women not enough fluent in French to benefit from clear and intelligible information
18 Years
FEMALE
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Jean-Olivier ARNAUD, Director
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
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Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
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Other Identifiers
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2020-A01303-36
Identifier Type: OTHER
Identifier Source: secondary_id
2020-30
Identifier Type: -
Identifier Source: org_study_id
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