COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy (COVADIS-PREG)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Respiratory Distress Syndrome Related to SARS-CoV-2
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • 40 Avenue de Verdun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women after 14 week of amenorrhoea with SARS-CoV-2 pneumonia requiring ICU admission for acute respiratory distress syndrome

Description

1. patient > 18 years
2. Patient with SARS-CoV-2 pneumonia proven by RT-PCR
3. Hospitalization in an intensive care unit during pregnancy after 14 weeks' gestation
4. Need for ventilatory support including: oxygen therapy > 6L/min and/or NIV and/or High Flow Oxygen and/or invasive mechanical ventilation +/- ECMO.

Exclusion Criteria:

• Patient's refusal to participate in this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	'Day 1.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient requiring invasive mechanical ventilation with or without ECMO	Number of patient requiring invasive mechanical ventilation with or without ECMO	'Day 1.
Number of patients receiving pharmacological treatments for the management of COVID: corticosteroids, antivirals, anti-IL6, anticoagulants, antibiotics	Number of patients receiving pharmacological treatments for the management of COVID: corticosteroids, antivirals, anti-IL6, anticoagulants, antibiotics	Day 1.
Evolution over time of the number of patients admitted to the ICU in the participating	Evolution over time of the number of patients admitted to the ICU in the participating centers (1st, 2nd, 3rd epidemic wave)	Day 1.
Evolution over time of the number of patients admitted to the ICU in the participating	Evolution over time of the number of patients admitted to the ICU in the participating	Day 1.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Frederique SCHORTGEN, PhD, Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): December 28, 2022
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Pregnancy; ICU; Acute respiratory distress syndrome; Critical Care; Mechanical ventilation; Preterm delivery; COVID-19,
• Additional Relevant MeSH Terms: Pathologic Processes; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: COVADIS PREG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No