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Clinical Trial Summary

In order to assess the mother-to-infant and potential vertical transmission of SARS-CoV-2 infection in pregnant women, maternal and neonatal biological samples will be prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals across Ontario. Samples will be tested for the SARS-CoV-2 serology and viral load. Outcomes for the study objective will be ascertained through the collection and testing of biological samples from the mother and/or infant. Specifically the investigators will: 1. Assess maternal nasopharyngeal or oropharyngeal swab, vaginal mucosa, ano-rectal swab, amniotic fluid, placenta (including subamniotic swab), breastmilk, cord blood and neonatal nasopharyngeal swab for RNA particles of coronavirus, by ddPCR. 2. Assess maternal serum for anti-coronavirus antibodies, by immunoassay. 3. Examine the impact of coronavirus on the neonate with respect to serology and viral load, in addition to placenta pathology findings and ddPCR. 4. Assess vertical transmission and the effect of coronavirus through placental pathology examination using placental pathology synoptic report.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04913948
Study type Observational
Source Ottawa Hospital Research Institute
Contact
Status Completed
Phase
Start date April 30, 2020
Completion date July 31, 2021

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