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Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women (PINK-CO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823234
Recruitment Status : Completed
First Posted : March 30, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine

Brief Summary:

SARS-CoV-2 impact on pregnant women is not well known yet. Some authors demonstrated that lung ultrasound can give similar results if compared to chest computed tomography and better results if compared to chest x-rays without radiations and limited risks for mother and fetus.

The Lung Ultrasound Score (LUS) can be used to asses the entity and monitor the evolution of lung impairment.

Some authors described an artifact, the "light beam", as a typical ultrasound sign in COVID-19 positive patients.

With our study we hypothesize to understand the prevalence of this sign and other ultrasound signs in pregnant COVID-19 positive patients.


Condition or disease Intervention/treatment
Pregnancy Complications Covid19 Diagnostic Test: Lung ultrasound

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women - "The PINK-CO Protocol"
Actual Study Start Date : March 10, 2021
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Diagnostic Test: Lung ultrasound
    Lung ultrasound signs in Covid 19 positive pregnant patients


Primary Outcome Measures :
  1. Light Beam [ Time Frame: 24 hours after admission ]
    Evaluate the prevalence of the light beam sign


Secondary Outcome Measures :
  1. Ultrasound patterns [ Time Frame: 24 hours after admission ]
    Evaluate the prevalence of ultrasound signs and patterns during pregnancy

  2. Lung ultrasound score [ Time Frame: 24 hours after admission ]
    Evaluate if the Lung ultrasound score relates with the clinical presentation of the patient

  3. Illness severity [ Time Frame: 24 hours after admission ]
    Evaluate if the lung ultrasound score relates with the prognosis

  4. Length of stay [ Time Frame: 24 hours after admission ]
    Evaluate if the lung ultrasound score relates with the length of stay



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All pregnant COVID 19 positive patients admitted at our institution
Criteria

Inclusion Criteria:

  • All pregnant COVID 19 positive patients admitted at our institution who had lung ultrasound performed

Exclusion Criteria:

  • are < 18 years old
  • history of rheumatic disease
  • history of spontaneous pneumothorax
  • fibrothorax
  • history of thoracic surgery
  • no consent given

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823234


Locations
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Italy
Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Udine, Italy, 33100
Sponsors and Collaborators
Azienda Sanitaria-Universitaria Integrata di Udine
Publications:

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Responsible Party: Luigi Vetrugno, Clinical Professor in Anesthesiology and Intensive Care, Azienda Sanitaria-Universitaria Integrata di Udine
ClinicalTrials.gov Identifier: NCT04823234    
Other Study ID Numbers: CEUR-2021-223
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pregnancy Complications
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases