Acute Respiratory Distress Syndrome Related to SARS-CoV-2COVADIS-PREGNCT05193526
COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy
An observational study of Acute Respiratory Distress Syndrome Related to SARS-CoV-2, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Respiratory Distress Syndrome Related to SARS-CoV-2
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women after 14 week of amenorrhoea with SARS-CoV-2 pneumonia requiring ICU admission for acute respiratory distress syndrome
Who may be able to join
None listed.
Who cannot join
- Patient's refusal to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- No intervention
- Keywords
- COVID-19,, Acute respiratory distress syndrome, Pregnancy, Preterm delivery, SARS-CoV-2, ICU, Critical Care, Mechanical ventilation
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 'Day 1.
Secondary outcomes (4)
Number of patient requiring invasive mechanical ventilation with or without ECMO
Number of patient requiring invasive mechanical ventilation with or without ECMO
Measured: '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
Measured: 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)
Measured: 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
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start15 Nov 2021
- Primary completion28 Dec 2022
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome Related to SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederique SCHORTGEN, PhD, Principal investigator, Centre Hospitalier Intercommunal Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193526
- Sponsor's protocol ID
- COVADIS PREG
- Acronym
- COVADIS-PREG
- Status last verified
- Sep 2023
- First submitted
- 3 Jan 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38890164
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COronaVirus Induced Acute Respiratory Disease Syndrome During PREGnancy
- ClinicalTrials.gov ID
- NCT05193526
- Acronym / sponsor ID
- COVADIS-PREG / COVADIS PREG
- Keywords
- COVID-19,, Acute respiratory distress syndrome, Pregnancy, Preterm delivery, SARS-CoV-2, ICU, Critical Care, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women after 14 week of amenorrhoea with SARS-CoV-2 pneumonia requiring ICU admission for acute respiratory distress syndrome
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patient's refusal to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
Time frame: '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
4 secondary outcomes
Number of patient requiring invasive mechanical ventilation with or without ECMO
Time frame: 'Day 1.
Number of patients receiving pharmacological treatments for the management of COVID: corticosteroids, antivirals, anti-IL6, anticoagulants, antibiotics
Time frame: Day 1.
Evolution over time of the number of patients admitted to the ICU in the participating
Time frame: Day 1.
Evolution over time of the number of patients admitted to the ICU in the participating
Time frame: Day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 38890164Schortgen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederique SCHORTGEN, PhD principal investigator
Centre Hospitalier Intercommunal Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome Related to SARS-CoV-2, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 'Day 1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05193526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.