NCT04823234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

March 26, 2021

Last Update Submit

September 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Light Beam

    Evaluate the prevalence of the light beam sign

    24 hours after admission

Secondary Outcomes (4)

  • Ultrasound patterns

    24 hours after admission

  • Lung ultrasound score

    24 hours after admission

  • Illness severity

    24 hours after admission

  • Length of stay

    24 hours after admission

Interventions

Lung ultrasoundDIAGNOSTIC_TEST

Lung ultrasound signs in Covid 19 positive pregnant patients

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All pregnant COVID 19 positive patients admitted at our institution

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Location

Related Publications (8)

  • 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.

    PMID: 32105680BACKGROUND
  • 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.

    PMID: 33281082BACKGROUND
  • 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.

    PMID: 32239532BACKGROUND
  • 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.

    PMID: 32366774BACKGROUND
  • Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit Care. 2014 Jun;20(3):315-22. doi: 10.1097/MCC.0000000000000096.

    PMID: 24758984BACKGROUND
  • 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.

    PMID: 25501898BACKGROUND
  • 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.

    PMID: 32860069BACKGROUND
  • 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.

MeSH Terms

Conditions

Pregnancy ComplicationsCOVID-19

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor in Anesthesiology and Intensive Care

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 30, 2021

Study Start

March 10, 2021

Primary Completion

June 30, 2021

Study Completion

September 15, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations