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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

Tracking Information
First Submitted Date March 26, 2021
First Posted Date March 30, 2021
Last Update Posted Date September 28, 2021
Actual Study Start Date March 10, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2021)
Light Beam [ Time Frame: 24 hours after admission ]
Evaluate the prevalence of the light beam sign
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2021)
  • Ultrasound patterns [ Time Frame: 24 hours after admission ]
    Evaluate the prevalence of ultrasound signs and patterns during pregnancy
  • Lung ultrasound score [ Time Frame: 24 hours after admission ]
    Evaluate if the Lung ultrasound score relates with the clinical presentation of the patient
  • Illness severity [ Time Frame: 24 hours after admission ]
    Evaluate if the lung ultrasound score relates with the prognosis
  • Length of stay [ Time Frame: 24 hours after admission ]
    Evaluate if the lung ultrasound score relates with the length of stay
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women
Official Title Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women - "The PINK-CO Protocol"
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All pregnant COVID 19 positive patients admitted at our institution
Condition
  • Pregnancy Complications
  • Covid19
Intervention Diagnostic Test: Lung ultrasound
Lung ultrasound signs in Covid 19 positive pregnant patients
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2021)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date September 15, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04823234
Other Study ID Numbers CEUR-2021-223
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine
Study Sponsor Azienda Sanitaria-Universitaria Integrata di Udine
Collaborators Not Provided
Investigators Not Provided
PRS Account Azienda Sanitaria-Universitaria Integrata di Udine
Verification Date September 2021