Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19

Study Overview
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Brief Summary
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Cohort prospective study. 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)

Official Title
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Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19

Conditions
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Pregnant Women Suspected of COVID-19

Intervention / Treatment
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* Device: Performing of lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years 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 giving an opposition to participate Women not enough fluent in French to benefit from clear and intelligible information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br>Pregnant women suspected of COVID-19 | Device: Performing of lung ultrasound<br>* Performing of lung ultrasound at bedside in labor ward or in COVID unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the lesions | 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). | 4 months |