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Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Sponsor: Boston University
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 10,000 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.
Official title: Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
10000
Start Date
2023-12-26
Completion Date
2028-06
Last Updated
2025-11-28
Healthy Volunteers
Not specified
Conditions
Interventions
Exposures
COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn
Locations (2)
Boston University School of Public Health, Global Health
Boston, Massachusetts, United States
Government. Medical College Hospital
Nagpur, India