NCT04432805

Terminated

Descriptive and Evaluation Study of the Use of Pulmonary Ult...

Assistance Publique Hopitaux De Marseille Source

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

2020-30

Secondary identifiers

2020-A01303-36

OTHER · ID RCB

Study Type

interventional

Actual enrollment (reported)

2

Locations

1 country

Sites

1

Timeline

Study Start

October 13, 2020

Actual (reported)

Primary Completion

January 2, 2021

Actual (reported)

Study Completion

January 2, 2021

Actual (reported)

Brief Summary

Cohort prospective study. Objectives : Primary objective: To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19 Secondary objectives:

To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions
To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant women
To evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed COVID-19
To describe the pregnancy issues of the study population Course of the study:
Inclusion of pregnant suspected of having COVID-19 and cared following the service protocol
Performing of lung ultrasound at bedside in labor ward or in COVID unit Primary outcome: Lung ultrasound lesions (and corresponding score) at the moment of the initial management of pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 2 participants
Study completion date: January 2, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 15, 2020
Actual (reported)
First Posted
June 16, 2020
Actual (reported)
Study Start
October 13, 2020
Actual (reported)
Primary Completion
January 2, 2021
Actual (reported)
Study Completion
January 2, 2021
Actual (reported)

Last Updated: August 12, 2022
Status Verified: August 2022
Last Update Submitted: August 10, 2022

Conditions

Pregnant Women Suspected of COVID-19

Outcome Measures

Primary Outcomes (1)

Description of the lesions
Description of the lesions in each of the 6 pulmonary quadrants on the right and left. Establishment of the ultrasound score corresponding to the sum of the scores attributed to each type of lesion in each quadrant (0: normal, 1: spaced comet tails, 2: curtain comet tails, 3: consolidation).
4 months

Study Arms (1)

Pregnant women

EXPERIMENTAL

Pregnant women suspected of COVID-19

Device: Performing of lung ultrasound

Interventions

Performing of lung ultrasoundDevice

Performing of lung ultrasound at bedside in labor ward or in COVID unit

Pregnant women

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age greater than or equal to 18 years
Gestational age greater than or equal to 22 weeks of gestation

Sponsors & Collaborators

Assistance Publique Hopitaux De Marseille
Otherlead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Study Officials

Jean-Olivier ARNAUD, Director
Assistance Publique Hôpitaux de Marseille
STUDY DIRECTOR

Enrollment

2 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 16, 2020

Study Start

October 13, 2020

Actual (reported)

Pregnant women suspected of COVID-19 :

already having a nasopharyngeal RT-PCR for the SARS-CoV-2

AND having a chest CT-scan or waiting for this exam

Women giving a writing consent to participate

You may not qualify if:

Women giving an opposition to participate
Women not enough fluent in French to benefit from clear and intelligible information

Contact the study team to confirm eligibility.

Primary Completion

January 2, 2021

Actual (reported)

Study Completion

January 2, 2021

Actual (reported)

Last Updated

August 12, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04432805
Data provider: ClinicalTrials.gov
Source updated: 2022-08-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:46 UTC

Locations

FR(1)

Study Stopped

Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Pregnant women

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Pregnant women

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations