跳至主要内容
临床试验/NCT05193526
NCT05193526进行中(未招募)不适用

COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy

Centre Hospitalier Intercommunal Creteil1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Compare two fetal extraction strategies: - Wait strategy defined by no extraction within 24 hours of invasive venting - Early strategy defined by extraction within 24 hours of invasive venting

研究概览

简要总结

Few data are available on the management of critically ill pregnant women with pneumonia related to SARS-CoV-2. In the absence of clear recommendations for the management of delivery, clinicians are faced with the risk of pregnancy continuation against the risk of premature birth. In these multicenter retrospective study, the investigators want to describe clinicians attitude on delivery management in pregnant women requiring invasive mechanical ventilation for acute respiratory distress syndrome related to SARS-CoV-2.

Two strategies will be compared on maternal, obstetric and neonatal outcomes:

  • Wait strategy defined by no extraction within 24 hours of invasive venting
  • Early strategy defined by extraction within 24 hours of invasive ventin

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patient's refusal to participate in this study

结局指标

主要结局

Compare two fetal extraction strategies: - Wait strategy defined by no extraction within 24 hours of invasive venting - Early strategy defined by extraction within 24 hours of invasive venting

时间窗: 'Day 1.

Assessment Criterion 1: Maternal prognosis assessed by: * Mortality * Duration of invasive mechanical ventilation * Need for ECMO * Use of prone position and/or nitric oxide and/or almitrine * Adverse events: cardiac arrest, organ failure, thromboembolic episodes, nosocomial infections, barotrauma * Length of stay in the ICU and in the hospital Assessment Criterion 2: Obstetric prognosis assessed by: * Fetal extraction in the ICU room due to a contraindication to transport (maternal and/or fetal risk) * Delivery route * Peri partum hemorrhage * Complications of obstetric anesthesias Assessment Criterion #3: Fetal Prognosis Assessed by: * Term birth, * Weight, * Apgar, * pH cord blood, * Need for ICU admission, * Death

次要结局

  • Number of patients receiving pharmacological treatments for the management of COVID: corticosteroids, antivirals, anti-IL6, anticoagulants, antibiotics(Day 1.)
  • Number of patient requiring invasive mechanical ventilation with or without ECMO('Day 1.)
  • Evolution over time of the number of patients admitted to the ICU in the participating(Day 1.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验