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

Sponsor
Azienda Sanitaria-Universitaria Integrata di Udine (Other)
Overall Status
Completed
CT.gov ID
NCT04823234
Collaborator
(none)
40
1
6.2
6.4

Study Details

Study Description

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 Phase
  • Diagnostic Test: Lung ultrasound

Study Design

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 :
Mar 10, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Sep 15, 2021

Outcome Measures

Primary Outcome Measures

  1. Light Beam [24 hours after admission]

    Evaluate the prevalence of the light beam sign

Secondary Outcome Measures

  1. Ultrasound patterns [24 hours after admission]

    Evaluate the prevalence of ultrasound signs and patterns during pregnancy

  2. Lung ultrasound score [24 hours after admission]

    Evaluate if the Lung ultrasound score relates with the clinical presentation of the patient

  3. Illness severity [24 hours after admission]

    Evaluate if the lung ultrasound score relates with the prognosis

  4. Length of stay [24 hours after admission]

    Evaluate if the lung ultrasound score relates with the length of stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD Udine Italy 33100

Sponsors and Collaborators

  • Azienda Sanitaria-Universitaria Integrata di Udine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Mar 30, 2021
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021