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

NCT04913948 | Completed Results

• 1 other identifier: CTO 2168
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 12

Brief 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. 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. 2.Assess maternal serum for anti-coronavirus antibodies, by immunoassay.
3. 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. 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

Outcome Measures

Primary Outcomes (2)

• Rate of Perinatal Transmission of SARS-CoV-2

  Evidence of SARS-CoV-2 RNA or antibodies against SARS-CoV-2 from a sterile (amniotic fluid) or non-sterile sample (nasopharyngeal swab sample, placental tissue, subamniotic swab or by cord blood serology \[for IgM or IgA\]) collected during the maternal hospital admission for delivery (specific time frame varied per participant).

  During the delivery admission

• Rate of Intrauterine Transmission of SARS-CoV-2

  Evidence of SARS-CoV-2 RNA or antibodies against SARS-CoV-2 in fetal tissues (i.e., amniotic fluid, placental tissue, sub-amniotic swab, cord blood) collected during maternal hospital admission for delivery (specific time frame varied per participant). Evidence of intrauterine transmission was determined using RT-PCR and serological analysis.

  During the delivery admission

Study Arms (1)

Pregnant

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

Pregnant

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women meeting the study eligibility criteria and delivering at a participating hospital within Ontario or Quebec will be recruited. Hospitals within the COPE Network include both Level II and III hospitals.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (12)

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L8E7, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2G1G3, Canada

Location

London Health Sciences

London, Ontario, N6A5W9, Canada

Location

North York General Hospital

North York, Ontario, M2K1E1, Canada

Location

Humber River Hospital

North York, Ontario, M3M 0B2, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

Hôpital Montfort

Ottawa, Ontario, K1K0T2, Canada

Location

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Should residual samples (i.e. maternal serum, umbilical cord serum, amniotic fluid, breast milk, placental tissue \[frozen and fixed\]) remain after the purposes of the primary outcomes, samples will be retained for 10 years for future, related REB approved studies.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

First, this was a convenience sample of individuals from Ontario and Quebec. Second, our ability to collect all samples from all participants was affected by local resources for safe sample collection, processing, storage, and patient preferences. Finally, our findings may not be generalizable to settings where SARS-CoV-2 community transmission rates and related outcomes varied significantly over the course of the pandemic, by variant and by local public health policies and practices.

Results Point of Contact

• Title: Dr. Darine El-Chaar
• Organization: Ottawa Hospital Research Institute

delchaar@toh.ca

(613) 737-8899

Study Officials

• Darine El-Chaar, MD, MSc

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: June 4, 2021
• Study Start: April 30, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (12)