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

Covid19 Clinical Trial

— COPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913948
• Other study ID #: CTO 2168
• Status: Completed
• Start date: April 30, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 will be prospectively collected from women with confirmed or suspected COVID-19 at participating hospitals across Ontario. Samples will be tested for the SARS-CoV-2 serology and viral load.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 one of the 13 participating hospitals within Ontario

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Infections
• Pregnancy
• SARS-CoV-2

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Grand River Hospital	Kitchener	Ontario
Canada	London Health Sciences	London	Ontario
Canada	Humber River Hospital	North York	Ontario
Canada	North York General Hospital	North York	Ontario
Canada	Hôpital Montfort	Ottawa	Ontario
Canada	The Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal and newborn viral titers	Maternal and newborn viral titers as measured in the following sample types: i. Maternal nasopharyngeal/oropharyngeal, vaginal and rectal swabs ii. Newborn nasopharyngeal swabs iii. Placenta iv. Subamniotic placenta swabs v. Amniotic fluid vi. Breastmilk	At the time of delivery
Primary	Maternal and newborn antibody titers	Maternal and newborn antibody titers as measured in the following sample types: i. Maternal blood ii. Cord blood iii. Amniotic fluid iv. Breastmilk v. Placenta	At the time of delivery
Primary	Placental morphology and histopathology	Placental morphology and histopathology using a standardized synoptic reporting framework for placental pathology. Specific outcomes that will be assessed are listed below: i. Maternal vascular malperfusion ii. Decidual vasculopathy iii. Implantation abnormalities iv. Intrauterine infection v. Placenta villous maldevelopment vi. Fetal vascular malperfusion vii. Chronic uteroplacental separation viii. Maternal-fetal interface disturbance ix. Chronic inflammation; Each of the outcomes listed above will examined using the standardized grading scale developed within the reporting framework. The grading scale ranges from 0 (not present), 1 (mildly present or low-grade) and 2 (severely present or high-grade).	At the time of delivery