Status:
UNKNOWN
International Lung UltraSound Analysis (ILUSA) Study
Lead Sponsor:
KU Leuven
Conditions:
COVID
Pregnancy Complications, Infectious
Eligibility:
FEMALE
Brief Summary
Currently there is a great need for an accurately and rapid assessment of patients suspected for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the initial triage of pa...
Detailed Description
During the current COVID-19 outbreak, all patient groups have been affected, also the most fragile such as the pregnant women. Although experts provided general suggestions on the best management of p...
Eligibility Criteria
Inclusion
- Participants eligible for inclusion in this Trial must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative obtained prior to any screening procedures
- Pregnant patients admitted to the Hospital during the COVID-19 pandemic:
- Patients with confirmed COVID-19 infection (see below)
- Symptomatic patients suspicious for COVID-19 infection (swab is taken on admission)
- Patients asymptomatic for COVID19 with other feto-maternal diseases or who come for delivery or caesarean section
- All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures.
- Definition of suspected case (WHO guideline, ISUOG)
- A patient with acute respiratory illness (fever and at least one sign/symptom of respiratory disease (e.g. cough, shortness of breath)) AND with no other etiology that fully explains the clinical presentation AND a history of travel to or residence in a country/area or territory reporting local transmission of COVID-19 infection during the 14 days prior to symptom onset; OR
- A patient with any acute respiratory illness AND who has been in contact with a confirmed or probable case of COVID-19 infection in the 14 days prior to onset of symptoms; OR
- A patient with severe acute respiratory infection (fever and at least one sign/symptom of respiratory disease (e.g. cough, shortness breath)) AND who requires hospitalization AND who has no other etiology that fully explains the clinical presentation.
Exclusion
- Participants eligible for this Trial must not meet any of the following criteria:
- Maternal lung pre-existing disease
- Maternal cardiac problems
- Severely ill patients in unstable condition requiring immediate life-saving procedures
- Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled in the Trial and will be identified on the Screening Log as Screen Failure.
Key Trial Info
Start Date :
April 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
1850 Patients enrolled
Trial Details
Trial ID
NCT04353141
Start Date
April 28 2020
End Date
December 31 2020
Last Update
May 7 2020
Active Locations (7)
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1
University Hospitals Leuven
Leuven, Belgium, 3000
2
University of Brescia
Brescia, Italy
3
University of Foggia
Foggia, Italy
4
University of Milan
Milan, Italy