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

NCT04913948 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 246

Last updated 2025-04-25

Study results available
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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.

Conditions

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

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Darine El-Chaar, MD, MSc · The Ottawa Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04913948 on ClinicalTrials.gov