Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06168019
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-12
Brief Title:
Influenza COVID-19 Obstetric and Perinatal Epidemiology Study in India
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Influenza COVID-19 Obstetric and Perinatal Epidemiology ICOPE Study in India
Status:
RECRUITING
Status Verified Date:
2023-12
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:
ICOPE
Brief Summary:
This study will be conducted as a prospective cohort study enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital Nagpur The Hospital provides primary secondary and tertiary care and the obstetric department delivers about 10000 babies a year The hypothesis is that co-infection of other respiratory viruses ORV particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy
Detailed Description:
All pregnant women enrolled in the study will receive standard of care throughout their pregnancy labor and delivery and post-partum to discharge Wherever possible study visits will coincide with regular antenatal ANC care and blood draws will be added to standard blood draws during ANC labor and delivery and postpartum care Women will be counselled about procedure to reduce the risk of acquiring ORV during pregnancy Since this study is observational we do not anticipate any specific safety concerns with study interviews and procedures but the investigators will monitor potential adverse events to determine if they are likely or possibly study related
PRIMARY OBJECTIVE Determine the prevalence incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 42 postpartumafter miscarriage on maternal outcomes Secondary analysis will evaluate whether influenzaOther Respiratory Viruses ORV infection or COVID-19 vaccination modifies or mediates this risk
SECONDARY OBJECTIVE Determine the effect of maternal COVID-19 infection on the fetus andor neonate during pregnancy through day 7 of life Secondary analysis will focus on whether influenzaORV or vaccination modifies and pre-term birth mediates this risk
EXPLORATORY OBJECTIVE Characterize patterns and trajectories of host response inflammatory biomarkers as potential mediators of COVID-19 Influenza and ORV infection on progression to severe illness in pregnant womenmothers admitted to Government Medical College hospital with COVID-19 Modifiers include COVID-19 Influenza and other ORV vaccinations
PRIMARY OBJECTIVE Determine the prevalence incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 42 postpartumafter miscarriage on maternal outcomes Secondary analysis will evaluate whether influenzaOther Respiratory Viruses ORV infection or COVID-19 vaccination modifies or mediates this risk
SECONDARY OBJECTIVE Determine the effect of maternal COVID-19 infection on the fetus andor neonate during pregnancy through day 7 of life Secondary analysis will focus on whether influenzaORV or vaccination modifies and pre-term birth mediates this risk
EXPLORATORY OBJECTIVE Characterize patterns and trajectories of host response inflammatory biomarkers as potential mediators of COVID-19 Influenza and ORV infection on progression to severe illness in pregnant womenmothers admitted to Government Medical College hospital with COVID-19 Modifiers include COVID-19 Influenza and other ORV vaccinations
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1HD078439 | NIH | None | httpsreporternihgovquickSearchUG1HD078439 |