Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India
Boston University
10,000 participants
Dec 26, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn
Locations(2)
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NCT06168019