Sars-CoV2 Clinical Trial
— TRANSCOVIDOfficial title:
Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy
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 |
Verified date | July 2021 |
Source | Centre Hospitalier Universitaire de Besancon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Besancon | Besancon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
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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