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

September 26, 2021 updated by: Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine

Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women - "The PINK-CO Protocol"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Udine, Italy, 33100
        • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All pregnant COVID 19 positive patients admitted at our institution

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light Beam
Time Frame: 24 hours after admission
Evaluate the prevalence of the light beam sign
24 hours after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound patterns
Time Frame: 24 hours after admission
Evaluate the prevalence of ultrasound signs and patterns during pregnancy
24 hours after admission
Lung ultrasound score
Time Frame: 24 hours after admission
Evaluate if the Lung ultrasound score relates with the clinical presentation of the patient
24 hours after admission
Illness severity
Time Frame: 24 hours after admission
Evaluate if the lung ultrasound score relates with the prognosis
24 hours after admission
Length of stay
Time Frame: 24 hours after admission
Evaluate if the lung ultrasound score relates with the length of stay
24 hours after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 26, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEUR-2021-223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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