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

Not Applicable

Terminated

• Conditions: Pregnant Women Suspected of COVID-19
• Interventions: Device: Performing of lung ultrasound

• Registration Number: NCT04432805
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Study Start: 2020-10-13
• Primary Completion: 2021-01-02
• Study Completion: 2021-01-02
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	Performing of lung ultrasound	Pregnant women suspected of COVID-19

Primary Outcome Measures

Name	Time	Method
Description of the lesions	4 months	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).

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France