NCT05193526

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

January 3, 2022

Last Update Submit

September 4, 2023

Conditions

Acute Respiratory Distress Syndrome Related to SARS-CoV-2

Keywords

COVID-19,Acute respiratory distress syndromePregnancyPreterm deliverySARS-CoV-2ICUCritical CareMechanical ventilation

Outcome Measures

Primary Outcomes (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

    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 Outcomes (4)

  • 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

    Day 1.

  • 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

    Day 1.

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • Patient's refusal to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

40 Avenue de Verdun

Créteil, 94000, France

Location

Related Publications (1)

  • Schortgen F, Tabra Osorio C, Demiri S, Dzogang C, Jung C, Lavenu A, Lecarpentier E; COVADIS-PREG study group. Management of pregnant women in tertiary maternity hospitals in the Paris area referred to the intensive care unit for acute hypoxaemic respiratory failure related to SARS-CoV-2: which practices for which outcomes? Ann Intensive Care. 2024 Jun 18;14(1):94. doi: 10.1186/s13613-024-01313-2.

    PMID: 38890164DERIVED

MeSH Terms

Conditions

COVID-19Respiratory Distress SyndromePremature Birth

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Frederique SCHORTGEN, PhD

    Centre Hospitalier Intercommunal Créteil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 18, 2022

Study Start

November 15, 2021

Primary Completion

December 28, 2022

Study Completion

November 30, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

FR(1)