Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04913948
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2021-03-03
Brief Title:
Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario Canada
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Assessing the Mother-to-infant Transmission Capabilities of COVID-19 Infection Among Pregnant Women in Ontario Canada
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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 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 andor 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
Outcomes for the study objective will be ascertained through the collection and testing of biological samples from the mother andor 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None