COVADIS-PREG: COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy
Study Details
Study Description
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:
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Wait strategy defined by no extraction within 24 hours of invasive venting
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Early strategy defined by extraction within 24 hours of invasive ventin
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- Number of patient requiring invasive mechanical ventilation with or without ECMO ['Day 1.]
Number of patient requiring invasive mechanical ventilation with or without ECMO
- 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
- 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 centers (1st, 2nd, 3rd epidemic wave)
- 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
Eligibility Criteria
Criteria
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patient > 18 years
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Patient with SARS-CoV-2 pneumonia proven by RT-PCR
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Hospitalization in an intensive care unit during pregnancy after 14 weeks' gestation
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | 40 Avenue de Verdun | Créteil | France | 94000 |
Sponsors and Collaborators
- Centre Hospitalier Intercommunal Creteil
Investigators
- Principal Investigator: Frederique SCHORTGEN, PhD, Centre Hospitalier Intercommunal Créteil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COVADIS PREG