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

  • STATUS
    Recruiting
  • participants needed
    160
  • sponsor
    Assistance Publique Hopitaux De Marseille
Updated on 19 February 2024

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)

Details
Condition Pregnant Women Suspected of COVID-19
Age 18-100 years
Treatment Performing of lung ultrasound
Clinical Study IdentifierNCT04432805
SponsorAssistance Publique Hopitaux De Marseille
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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