Pregnant Women Suspected of COVID-19 Clinical Trial
— LUSCOVIDPREGOfficial title:
Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
| Verified date | August 2022 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | January 2, 2021 |
| Est. primary completion date | January 2, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |