Organizational Impact of Rapid Screening for COVID-19 by Delocalized Biology in the Birth Room (DELOCOVIDMATER)

October 31, 2022 updated by: Groupe Hospitalier Paris Saint Joseph

COVID-19 disease, caused by SARS-CoV-2 first appeared in China, and then spread worldwide. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei Province, China. Very quickly, a new coronavirus was isolated from a sample of a patient's lower respiratory tract and the complete genome of the virus was sequenced. This new coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) for its genetic homology with SARS-CoV, showed a global extension. Thus, on January 30, 2020, the World Health Organization (WHO) announced the outbreak of COVID-19 as an international public health threat, and then in March 2020, the global situation escalated to a pandemic. Johns Hopkins University reported over 7,600,000 cases of infection and over 427,000 deaths as of June 13, 2020. Due to the rapid progression of the COVID-19 pandemic and the limited molecular testing capabilities at the laboratory level, the concept of molecular testing for off-site biology examination appears relevant. Indeed, the urgent need for increased testing for COVID-19 has been clearly identified as an essential element of the strategy to combat the coronavirus worldwide. Indeed, COVID-19 represents a major public health problem currently causing rapidly increasing numbers of infections and significant morbidity and mortality worldwide. As of September 3, 2021, more than 200 million people worldwide have been infected with SARS-CoV-2 and more than 4.5 million have died according to data collected by Johns Hopkins University. Early detection with a sensitive COVID-19 technique is essential to ensure rapid and appropriate patient management, contain the epidemic, and better understand the global epidemiology of the virus. To date, laboratory diagnostics have relied primarily on amplification and detection of viral gene sequences in upper respiratory tract specimens performed in a centralized laboratory. A new test (ID NOW COVID-19) is based on isothermal amplification at 56°C of the gene encoding the RdRp RNA polymerase. This molecular biology test can be performed as an off-site medical examination (EBMD), providing a result in less than 13 minutes directly in the clinical department. This rapidity could allow a more rapid management, isolation and "filiarization" of COVID-19 patients.

To our knowledge, there is no study available in the literature evaluating the impact of a rapid examination in delocalized biology on the organization of the management of pregnant women in the delivery room. The objective of this work is to evaluate the organizational impact of parturients who have received a rapid test for SARS-CoV-2.

The primary objective is to evaluate the impact of the use of the ID NOW COVID-19 test on the length of stay of parturients in the delivery room.

The secondary objectives are to evaluate the time to result, time to isolation and user satisfaction.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2447

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Parturient whose age is ≥ 18 years, in spontaneous labor betwenn July 2020 and July 2021.

Description

Inclusion Criteria:

  • Parturient whose age is ≥ 18 years
  • Parturient in spontaneous labor
  • French speaking parturient

Exclusion Criteria:

  • Parturient under guardianship or curatorship
  • Parturient deprived of liberty
  • Parturient under court protection
  • Parturient objecting to the use of her data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the use of the ID NOW COVID-19 test on the length of stay of parturients in the delivery room
Time Frame: Day 1
This outcome corresponds to the time of presence of the parturient in the birth room.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rendering time of the result
Time Frame: Day 1
This outcome corresponds to the rendering time of the result.
Day 1
Time to implement isolation
Time Frame: Day 1
This outcome corresponds to the time to implement isolation.
Day 1
User satisfaction
Time Frame: Day 1
This outcome corresponds to the user satisfaction.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Jean-Claude NGUYEN VAN, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Actual)

August 14, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DELOCOVIDMATER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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