COVADIS-PREG: COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05193526
Collaborator
(none)
100
1
12.5
8

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

  • Early strategy defined by extraction within 24 hours of invasive ventin

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Sep 28, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Number of patient requiring invasive mechanical ventilation with or without ECMO ['Day 1.]

    Number of patient requiring invasive mechanical ventilation with or without ECMO

  2. 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

  3. 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)

  4. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
  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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT05193526
Other Study ID Numbers:
  • COVADIS PREG
First Posted:
Jan 18, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Intercommunal Creteil
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2022