COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy

Active, not recruiting

• Conditions: Acute Respiratory Distress Syndrome Related to SARS-CoV-2

• Registration Number: NCT05193526
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-15
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-18
• Primary Completion: 2022-12-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

• Patient's refusal to participate in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	'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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

40 Avenue de Verdun; 🇫🇷 Créteil, France