Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04913948
Acronym
COPE
Enrollment
246
Registered
2021-06-04
Start date
2020-04-30
Completion date
2021-07-31
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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. 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.

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Perinatal Transmission of SARS-CoV-2During the delivery admissionEvidence 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-2During the delivery admissionEvidence 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.

Countries

Canada

Participant flow

Participants by arm

ArmCount
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 No intervention: No intervention
242
Total242

Withdrawals & dropouts

PeriodReasonFG000
Overall StudySample processing issues1
Overall StudySuspected to have COVID-19 at the time of delivery but was found to be negative upon RT-PCR testing1
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicPregnant
Age, Continuous31.2 years
STANDARD_DEVIATION 5.3
Gestational weight gain
Less than recommended
50 Participants
Gestational weight gain
Missing
37 Participants
Gestational weight gain
More than recommended
112 Participants
Gestational weight gain
Within recommended range
43 Participants
Neighbourhood family income quintile
Missing
32 Participants
Neighbourhood family income quintile
Quintile 1 (lowest)
60 Participants
Neighbourhood family income quintile
Quintile 2
48 Participants
Neighbourhood family income quintile
Quintile 3
40 Participants
Neighbourhood family income quintile
Quintile 4
34 Participants
Neighbourhood family income quintile
Quintile 5
28 Participants
Parity
Missing
37 Participants
Parity
Multiparous
112 Participants
Parity
Nulliparous
50 Participants
Parity
Primiparous
43 Participants
Pre-pregnancy BMI
<18.5
6 Participants
Pre-pregnancy BMI
18.5 to <25
93 Participants
Pre-pregnancy BMI
25 to >30
68 Participants
Pre-pregnancy BMI
>=30
67 Participants
Pre-pregnancy BMI
Missing
8 Participants
Race/Ethnicity, Customized
Asian
35 Participants
Race/Ethnicity, Customized
Black
43 Participants
Race/Ethnicity, Customized
Caucasian
69 Participants
Race/Ethnicity, Customized
Missing
75 Participants
Race/Ethnicity, Customized
Other/Unknown/Mixed ethnicity
20 Participants
Sex: Female, Male
Female
242 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 242
other
Total, other adverse events
0 / 242
serious
Total, serious adverse events
0 / 242

Outcome results

Primary

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.

Time frame: During the delivery admission

ArmMeasureValue (NUMBER)
PregnantRate of Intrauterine Transmission of SARS-CoV-24.4 percentage of participants
Primary

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).

Time frame: During the delivery admission

Population: The rate of perinatal transmission of SARS-CoV-2 was estimated based on one or more positive test results by RT-PCR for 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). A total of 227 participant provided the appropriate samples for analysis.

ArmMeasureValue (NUMBER)
PregnantRate of Perinatal Transmission of SARS-CoV-212.3 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026