Pregnant Women Suspected of COVID-19LUSCOVIDPREGNCT04432805
Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
A study testing Performing of lung ultrasound in people with Pregnant Women Suspected of COVID-19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Cohort prospective study. Objectives : Primary objective: To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19 Secondary objectives: To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions To evaluate the performances of the lung… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women Suspected of COVID-19
- What is being tested?
- Performing of lung ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2020to 2 Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- Age greater than or equal to 18 years
- Gestational age greater than or equal to 22 weeks of gestation
- Pregnant women suspected of COVID-19 :
- already having a nasopharyngeal RT-PCR for the SARS-CoV-2
- AND having a chest CT-scan or waiting for this exam
- Women giving a writing consent to participate
Who cannot join
- Women giving an opposition to participate
- Women not enough fluent in French to benefit from clear and intelligible information
Trial locations and contacts
1 site in 1 country.
About this study
Cohort prospective study.
Objectives :
Read more
Primary objective:
To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19
Secondary objectives:
- To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions
- To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant women
- To evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed COVID-19
- To describe the pregnancy issues of the study population
Course of the study:
- Inclusion of pregnant suspected of having COVID-19 and cared following the service protocol
- Performing of lung ultrasound at bedside in labor ward or in COVID unit
Primary outcome:
Lung ultrasound lesions (and corresponding score) at the moment of the initial management of pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)
- Conditions
- Pregnant Women Suspected of COVID-19
- Being tested
- Performing of lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing of lung ultrasoundDevice
Performing of lung ultrasound at bedside in labor ward or in COVID unit
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | Pregnant women suspected of COVID-19 Receives: Device: Performing of lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the lesions
Description of the lesions in each of the 6 pulmonary quadrants on the right and left. Establishment of the ultrasound score corresponding to the sum of the scores attributed to each type of lesion in each quadrant (0: normal, 1: spaced comet tails, 2: curtain comet tails, 3: consolidation).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start13 Oct 2020
- Primary completion2 Jan 2021
- Study completion2 Jan 2021
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women Suspected of COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432805
- Sponsor's protocol ID
- 2020-30
- Other IDs
- 2020-A01303-36
- Acronym
- LUSCOVIDPREG
- Status last verified
- Aug 2022
- First submitted
- 15 Jun 2020
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19
- ClinicalTrials.gov ID
- NCT04432805
- Acronym / sponsor ID
- LUSCOVIDPREG / 2020-30
- Conditions
- Pregnant Women Suspected of COVID-19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 16 Jun 2020 (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.
Cohort prospective study.
Objectives :
Primary objective:
To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19
Secondary objectives:
- To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions
- To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant women
- To evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed COVID-19
- To describe the pregnancy issues of the study population
Course of the study:
- Inclusion of pregnant suspected of having COVID-19 and cared following the service protocol
- Performing of lung ultrasound at bedside in labor ward or in COVID unit
Primary outcome:
Lung ultrasound lesions (and corresponding score) at the moment of the initial management of pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Device: Performing of lung ultrasoundPregnant women suspected of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- Gestational age greater than or equal to 22 weeks of gestation
- Pregnant women suspected of COVID-19 :
- already having a nasopharyngeal RT-PCR for the SARS-CoV-2
- AND having a chest CT-scan or waiting for this exam
Key exclusion criteria (2 listed)
- Women giving an opposition to participate
- Women not enough fluent in French to benefit from clear and intelligible information
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 |
|---|---|---|
| Performing of lung ultrasoundPerforming of lung ultrasound at bedside in labor ward or in COVID unit | Device | Pregnant women |
Primary outcome
Description of the lesions
Time frame: 4 months
Description of the lesions in each of the 6 pulmonary quadrants on the right and left. Establishment of the ultrasound score corresponding to the sum of the scores attributed to each type of lesion in each quadrant (0: normal, 1: spaced comet tails, 2: curtain comet tails, 3: consolidation).
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
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.
Jean-Olivier ARNAUD, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performing of lung ultrasound in people with Pregnant Women Suspected of COVID-19, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 12 Aug 2022. 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?
The study was stopped early (reason given: recruitment issues). 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?
Description of the lesions (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2022.