Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India

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.

NCT Number	NCT06168019
Lead Sponsor	Boston University Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lata Medical Research Foundation, Nagpur
Conditions	Influenza, COVID-19, SARS-COV-2 Infection, Other Respiratory Viruses, Perinatal Morbidity, Infant Morbidity
Enrollment	10,000 participants
Start Date	2023-12-26
Primary Completion	2028-06 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2025-11-28