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NCT04402918 Clinical Trial

Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy

Sars-CoV2 Clinical Trial

— TRANSCOVID  

Official title:
Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04402918
Other study ID # 2020/500
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 17, 2020
Est. completion date August 2, 2021

Study information
Verified date July 2021
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date August 2, 2021
Est. primary completion date May 19, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - pregnant woman - diagnosed with Sars Cov-2 during pregnancy - singleton or twin pregnancy - informed consent Exclusion Criteria: - virological or serological samples not done the day of delivery

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• biological samples day of delivery
mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration

Locations
Country Name City State
France Chu Besancon Besancon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vrological profile of newborns. Describe the virological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : Covid+ or covid- day of delivery
Primary Immunological profile of newborns. Describe the immunological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : IgG and/or IgM or absence day of delivery
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