Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Description of the lesions
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Women giving an opposition to participate
- •Women not enough fluent in French to benefit from clear and intelligible information
研究组 & 干预措施
Pregnant women
Pregnant women suspected of COVID-19
干预措施: Performing of lung ultrasound (Device)
结局指标
主要结局
Description of the lesions
时间窗: 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).
次要结局
未报告次要终点