Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT04823234
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Light Beam', 'timeFrame': '24 hours after admission', 'description': 'Evaluate the prevalence of the light beam sign'}], 'secondaryOutcomes': [{'measure': 'Ultrasound patterns', 'timeFrame': '24 hours after admission', 'description': 'Evaluate the prevalence of ultrasound signs and patterns during pregnancy'}, {'measure': 'Lung ultrasound score', 'timeFrame': '24 hours after admission', 'description': 'Evaluate if the Lung ultrasound score relates with the clinical presentation of the patient'}, {'measure': 'Illness severity', 'timeFrame': '24 hours after admission', 'description': 'Evaluate if the lung ultrasound score relates with the prognosis'}, {'measure': 'Length of stay', 'timeFrame': '24 hours after admission', 'description': 'Evaluate if the lung ultrasound score relates with the length of stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Complications', 'Covid19']}, 'referencesModule': {'references': [{'pmid': '32105680', 'type': 'BACKGROUND', 'citation': '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': '33281082', 'type': 'BACKGROUND', 'citation': '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': '32239532', 'type': 'BACKGROUND', 'citation': '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': '32366774', 'type': 'BACKGROUND', 'citation': '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': '24758984', 'type': 'BACKGROUND', 'citation': 'Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit Care. 2014 Jun;20(3):315-22. doi: 10.1097/MCC.0000000000000096.'}, {'pmid': '25501898', 'type': 'BACKGROUND', 'citation': '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': '32860069', 'type': 'BACKGROUND', 'citation': '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': '35127744', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe Lung Ultrasound Score (LUS) can be used to asses the entity and monitor the evolution of lung impairment.\n\nSome authors described an artifact, the "light beam", as a typical ultrasound sign in COVID-19 positive patients.\n\nWith our study we hypothesize to understand the prevalence of this sign and other ultrasound signs in pregnant COVID-19 positive patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant COVID 19 positive patients admitted at our institution', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All pregnant COVID 19 positive patients admitted at our institution who had lung ultrasound performed\n\nExclusion Criteria:\n\n* are \\< 18 years old\n* history of rheumatic disease\n* history of spontaneous pneumothorax\n* fibrothorax\n* history of thoracic surgery\n* no consent given'}, 'identificationModule': {'nctId': 'NCT04823234', 'acronym': 'PINK-CO', 'briefTitle': 'Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria-Universitaria Integrata di Udine'}, 'officialTitle': 'Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women - "The PINK-CO Protocol"', 'orgStudyIdInfo': {'id': 'CEUR-2021-223'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lung ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lung ultrasound signs in Covid 19 positive pregnant patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria-Universitaria Integrata di Udine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor in Anesthesiology and Intensive Care', 'investigatorFullName': 'Luigi Vetrugno', 'investigatorAffiliation': 'Azienda Sanitaria-Universitaria Integrata di Udine'}}}}