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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Terminated

Conditions: Pregnant Women Suspected of COVID-19

Treatments: Device: Performing of lung ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04432805

2020-30

2020-A01303-36 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2 participants in 1 patient group

Pregnant women

Experimental group

Description:

Pregnant women suspected of COVID-19

Treatment:

Device: Performing of lung ultrasound