Back to resultsDescriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19 (LUSCOVIDPREG)
Primary Purpose
Pregnant Women Suspected of COVID-19
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Performing of lung ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Pregnant Women Suspected of COVID-19
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pregnant women
Arm Description
Pregnant women suspected of COVID-19
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04432805
First Posted
June 15, 2020
Last Updated
August 10, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04432805
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
Acronym
LUSCOVIDPREG
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
recruitment issues
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
January 2, 2021 (Actual)
Study Completion Date
January 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnant Women Suspected of COVID-19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant women
Arm Type
Experimental
Arm Description
Pregnant women suspected of COVID-19
Intervention Type
Device
Intervention Name(s)
Performing of lung ultrasound
Intervention Description
Performing of lung ultrasound at bedside in labor ward or in COVID unit
Primary Outcome Measure Information:
Title
Description of the lesions
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).
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
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