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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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04432805
Acronym
LUSCOVIDPREG
Enrollment
2
Registered
2020-06-16
Start date
2020-10-13
Completion date
2021-01-02
Last updated
2022-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women Suspected of COVID-19

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)

Interventions

DEVICEPerforming of lung ultrasound

Performing of lung ultrasound at bedside in labor ward or in COVID unit

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Description of the lesions4 monthsDescription 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026