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:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
Official Title:
Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUSCOVIDPREG
Brief Summary:
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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A01303-36 | OTHER | ID RCB | View |