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Pregnancy ComplicationsPINK-CONCT04823234

Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women

An observational study of Pregnancy Complications and Covid19, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Pregnancy Complications, Covid19
What is being tested?
Lung ultrasound
How many people
40 participants
Where
1 siteItaly
Study dates
10 Mar 2021to 15 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: All pregnant COVID 19 positive patients admitted at our institution

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

    Udine, 33100

Other trials in Italy

About this study

Official title: 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.

Being tested
Lung ultrasound
Medical subject headings
Pregnancy Complications, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung ultrasoundDiagnostic test

    Lung ultrasound signs in Covid 19 positive pregnant patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Light Beam

    Evaluate the prevalence of the light beam sign

    Measured: 24 hours after admission

Secondary outcomes (4)

  1. Ultrasound patterns

    Evaluate the prevalence of ultrasound signs and patterns during pregnancy

    Measured: 24 hours after admission

  2. Lung ultrasound score

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

    Measured: 24 hours after admission

  3. Illness severity

    Evaluate if the lung ultrasound score relates with the prognosis

    Measured: 24 hours after admission

  4. Length of stay

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

    Measured: 24 hours after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2021
  2. Study start10 Mar 2021
  3. Primary completion30 Jun 2021
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04823234
Sponsor's protocol ID
CEUR-2021-223
Acronym
PINK-CO
Status last verified
Sep 2021
First submitted
26 Mar 2021
Last updated
28 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rasmussen SA, Smulian JC, Lednicky JA, Wen TS, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and pregnancy: what obstetricians need to know. Am J Obstet Gynecol. 2020 May;222(5):415-426. doi: 10.1016/j.ajog.2020.02.017. Epub 2020 Feb 24.

    PubMed 32105680

  • Li J, Long X, Wang X, Fang F, Lv X, Zhang D, Sun Y, Hu S, Lin Z, Xiong N. Radiology indispensable for tracking COVID-19. Diagn Interv Imaging. 2021 Feb;102(2):69-75. doi: 10.1016/j.diii.2020.11.008. Epub 2020 Nov 24.

    PubMed 33281082

  • Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15.

    PubMed 32239532

  • Convissar DL, Gibson LE, Berra L, Bittner EA, Chang MG. Application of Lung Ultrasound During the COVID-19 Pandemic: A Narrative Review. Anesth Analg. 2020 Aug;131(2):345-350. doi: 10.1213/ANE.0000000000004929.

    PubMed 32366774

  • Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit Care. 2014 Jun;20(3):315-22. doi: 10.1097/MCC.0000000000000096.

    PubMed 24758984

  • Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.

    PubMed 25501898

  • Lichter Y, Topilsky Y, Taieb P, Banai A, Hochstadt A, Merdler I, Gal Oz A, Vine J, Goren O, Cohen B, Sapir O, Granot Y, Mann T, Friedman S, Angel Y, Adi N, Laufer-Perl M, Ingbir M, Arbel Y, Matot I, Szekely Y. Lung ultrasound predicts clinical course and outcomes in COVID-19 patients. Intensive Care Med. 2020 Oct;46(10):1873-1883. doi: 10.1007/s00134-020-06212-1. Epub 2020 Aug 28.

    PubMed 32860069

  • Vetrugno L, Sala A, Orso D, Meroi F, Fabbro S, Boero E, Valent F, Cammarota G, Restaino S, Vizzielli G, Girometti R, Merelli M, Tascini C, Bove T, Driul L; PINK-CO study investigators. Lung Ultrasound Signs and Their Correlation With Clinical Symptoms in COVID-19 Pregnant Women: The "PINK-CO" Observational Study. Front Med (Lausanne). 2022 Jan 21;8:768261. doi: 10.3389/fmed.2021.768261. eCollection 2021.

    PubMed 35127744

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Complications and Covid19, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Light Beam (time frame: 24 hours after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04823234, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.

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