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

Completed

• Conditions: Labor; COVID-19

• Registration Number: NCT05175716
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-04
• Study Start: 2022-01-14
• Status Verified: 2022-06
• Primary Completion: 2022-08-14
• Study Completion: 2022-10-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2447

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to implement isolation	Day 1	This outcome corresponds to the time to implement isolation.
Rendering time of the result	Day 1	This outcome corresponds to the rendering time of the result.
User satisfaction	Day 1	This outcome corresponds to the user satisfaction.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France