SARS-CoV-2COPENCT04913948
Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario, Canada
An observational study of SARS-CoV-2 and Covid19, run by Ottawa Hospital Research Institute at 12 sites in Canada.
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 were prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- SARS-CoV-2, Covid19, Corona Virus Infection
- How many people
- 246 participants
- Where
- 12 sitesCanada
- Study dates
- 30 Apr 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L8E7
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Grand River Hospital
Kitchener, Ontario, N2G1G3
London Health Sciences
London, Ontario, N6A5W9
North York General Hospital
North York, Ontario, M2K1E1
Humber River Hospital
North York, Ontario, M3M 0B2
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H8L6
Hôpital Montfort
Ottawa, Ontario, K1K0T2
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y4E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
About this study
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:
- 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.
Read the detailed description
Pregnant individuals with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection were more likely to experience greater disease severity and higher rates of hospitalization, intensive care unit (ICU) admission and death compared to their non-pregnant counterparts. Early pandemic data were limited to a few small case series and reports that failed to provide a clear understanding of the timing and likelihood of fetal/neonatal infection. Data now suggest that in utero, intrapartum and early postnatal transmission of SARS-CoV-2 to the fetus/neonate is rare (<5%) and predominantly associated with third trimester infections and severe disease presentation. A living systematic review and meta-analysis of 144 cohort studies found that the rate neonates/fetuses testing positive for SARS-CoV-2 by RT-PCR, having anti-SARS-CoV-2 IgM antibodies or both was 1.94% (95%CI 1.31%, 2.66%). However, tests for SARS-CoV-2 and anti-SARS-CoV-2 antibodies were limited during the earliest stages of the pandemic and relatively few of the included studies provided sufficient data on the timing of fetal/neonatal exposure, and the type and timing of tests performed.
Derivation of reliable risk estimates for perinatal transmission remains challenging due to significant heterogeneity across published studies regarding the types of tissues profiled, diagnostic methods used and availability of essential COVID-19 disease characteristics such as timing and severity of maternal infection. As variants of concern continue to emerge, more data are required to elucidate the circumstances in which SARS-CoV-2 infection is likely to be transmitted to the developing fetus/neonate. We sought to evaluate the rate of SARS-CoV-2 transmission from mother-to-neonate in a large multicenter cohort from Ontario and Quebec, Canada.
To address early pandemic challenges in characterizing perinatal infections, a prospective cohort study was conducted across 14 sites in Ontario and Quebec, Canada. Pregnant individuals who had received a diagnosis of SARS-CoV-2 infection in pregnancy were eligible. Sample collection at delivery included maternal samples (nasopharyngeal/oropharyngeal, vaginal and anorectal swabs; blood; breastmilk), newborn samples (nasopharyngeal swabs, cord blood, amniotic fluid), and placental samples (sub-amniotic swab, placental biopsies). Swab, amniotic fluid, placenta and breastmilk samples were analyzed for SARS-CoV-2 RNA by RT-qPCR. Blood, breastmilk and amniotic fluid were assessed for anti-SARS-CoV-2 spike (S), receptor binding domain (RBD) and nucleocapsid (N) IgG, IgM and IgA.
- Conditions
- SARS-CoV-2, Covid19, Corona Virus Infection, Infectious Disease Transmission, Vertical, Pregnancy
- Being tested
- No intervention
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: During the delivery admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start30 Apr 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Darine El-Chaar, MD, MSc, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913948
- Sponsor's protocol ID
- CTO 2168
- Acronym
- COPE
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2021
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario, Canada
- ClinicalTrials.gov ID
- NCT04913948
- Acronym / sponsor ID
- COPE / CTO 2168
- Conditions
- SARS-CoV-2, Covid19, Corona Virus Infection, Infectious Disease Transmission, Vertical, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
Pregnant individuals with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection were more likely to experience greater disease severity and higher rates of hospitalization, intensive care unit (ICU) admission and death compared to their non-pregnant counterparts. Early pandemic data were limited to a few small case series and reports that failed to provide a clear understanding of the timing and likelihood of fetal/neonatal infection. Data now suggest that in utero, intrapartum and early postnatal transmission of SARS-CoV-2 to the fetus/neonate is rare (<5%) and predominantly associated with third trimester infections and severe disease presentation. A living systematic review and meta-analysis of 144 cohort studies found that the rate neonates/fetuses testing positive for SARS-CoV-2 by RT-PCR, having anti-SARS-CoV-2 IgM antibodies or both was 1.94% (95%CI 1.31%, 2.66%). However, tests for SARS-CoV-2 and anti-SARS-CoV-2 antibodies were limited during the earliest stages of the pandemic and relatively few of the included studies provided sufficient data on the timing of fetal/neonatal exposure, and the type and timing of tests performed.
Derivation of reliable risk estimates for perinatal transmission remains challenging due to significant heterogeneity across published studies regarding the types of tissues profiled, diagnostic methods used and availability of essential COVID-19 disease characteristics such as timing and severity of maternal infection. As variants of concern continue to emerge, more data are required to elucidate the circumstances in which SARS-CoV-2 infection is likely to be transmitted to the developing fetus/neonate. We sought to evaluate the rate of SARS-CoV-2 transmission from mother-to-neonate in a large multicenter cohort from Ontario and Quebec, Canada.
To address early pandemic challenges in characterizing perinatal infections, a prospective cohort study was conducted across 14 sites in Ontario and Quebec, Canada. Pregnant individuals who had received a diagnosis of SARS-CoV-2 infection in pregnancy were eligible. Sample collection at delivery included maternal samples (nasopharyngeal/oropharyngeal, vaginal and anorectal swabs; blood; breastmilk), newborn samples (nasopharyngeal swabs, cord blood, amniotic fluid), and placental samples (sub-amniotic swab, placental biopsies). Swab, amniotic fluid, placenta and breastmilk samples were analyzed for SARS-CoV-2 RNA by RT-qPCR. Blood, breastmilk and amniotic fluid were assessed for anti-SARS-CoV-2 spike (S), receptor binding domain (RBD) and nucleocapsid (N) IgG, IgM and IgA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant | – | Other: No interventionPregnant 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Pregnant |
Primary outcome
Rate of Perinatal Transmission of SARS-CoV-2
Time frame: During the delivery admission
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).
Rate of Intrauterine Transmission of SARS-CoV-2
Time frame: During the delivery admission
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD that underlie the results reported in this article, after deidentification, will be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darine El-Chaar, MD, MSc principal investigator
The Ottawa Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and Covid19, run by Ottawa Hospital Research Institute at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Perinatal Transmission of SARS-CoV-2 (time frame: During the delivery admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.