N/A
Completed N=246
Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario, Canada
SARS-CoV-2 infection · Covid19 · Corona Virus Infection · Infectious Disease Transmission, Vertical
Source: ClinicalTrials.gov NCT04913948 ↗
Enrolled (actual)
246
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Rate of Perinatal Transmission of SARS-CoV-2 — 12.3 percentage of participants
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 were prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals. Samples were be tested for the SARS-CoV-2 serology and presence of SARS-CoV-2 RNA.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Perinatal Transmission of SARS-CoV-2 |
12.3 | — |
| PRIMARY Rate of Intrauterine Transmission of SARS-CoV-2 |
4.4 | — |
Eligibility Criteria
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 a participating hospital in Ontario or Quebec
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04913948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.