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COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy

COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05193526
Acronym
COVADIS-PREG
Enrollment
100
Registered
2022-01-18
Start date
2021-11-15
Completion date
2023-11-30
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome Related to SARS-CoV-2

Keywords

COVID-19,, Acute respiratory distress syndrome, Pregnancy, Preterm delivery, SARS-CoV-2, ICU, Critical Care, Mechanical ventilation

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

Interventions

OTHERNo intervention

No intervention

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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, antibioticsDay 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 participatingDay 1.Evolution over time of the number of patients admitted to the ICU in the participating centers (1st, 2nd, 3rd epidemic wave)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026