Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario, Canada

Study Overview
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Brief Summary
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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: 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. Assess maternal serum for anti-coronavirus antibodies, by immunoassay. Examine the impact of coronavirus on the neonate with respect to serology and viral load, in addition to placenta pathology findings and ddPCR. Assess vertical transmission and the effect of coronavirus through placental pathology examination using placental pathology synoptic report.

Official Title
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Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario, Canada

Conditions
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SARS-CoV-2, Covid19, Corona Virus Infection, Infectious Disease Transmission, Vertical, Pregnancy

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with confirmed COVID-19 at any point during pregnancy or suspected COVID-19 at time of delivery (as identified at local hospital) , who will be delivering at one of the 13 participating hospitals within Ontario Exclusion Criteria: None
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant<br>Pregnant women with confirmed COVID-19 at any point during pregnancy or suspected (as identified at local hospital) of COVID-19 at time of delivery, who will be delivering at a participating hospital within Ontario | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and newborn viral titers | Maternal and newborn viral titers as measured in the following sample types: i. Maternal nasopharyngeal/oropharyngeal, vaginal and rectal swabs ii. Newborn nasopharyngeal swabs iii. Placenta iv. Subamniotic placenta swabs v. Amniotic fluid vi. Breastmilk | At the time of delivery | 
| Maternal and newborn antibody titers | Maternal and newborn antibody titers as measured in the following sample types: i. Maternal blood ii. Cord blood iii. Amniotic fluid iv. Breastmilk v. Placenta | At the time of delivery | 
| Placental morphology and histopathology | Placental morphology and histopathology using a standardized synoptic reporting framework for placental pathology. Specific outcomes that will be assessed are listed below: i. Maternal vascular malperfusion ii. Decidual vasculopathy iii. Implantation abnormalities iv. Intrauterine infection v. Placenta villous maldevelopment vi. Fetal vascular malperfusion vii. Chronic uteroplacental separation viii. Maternal-fetal interface disturbance ix. Chronic inflammation Each of the outcomes listed above will examined using the standardized grading scale developed within the reporting framework. The grading scale ranges from 0 (not present), 1 (mildly present or low-grade) and 2 (severely present or high-grade). | At the time of delivery |