NCT06168019

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Boston University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: —

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.

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 postpartum/after miscarriage on maternal outcomes. Secondary analysis will evaluate whether influenza/Other 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 and/or neonate during pregnancy through day 7 of life. Secondary analysis will focus on whether influenza/ORV 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 women/mothers admitted to Government Medical College hospital with COVID-19. Modifiers include COVID-19 , Influenza and other ORV vaccinations.

Conditions

• Influenza
• COVID-19
• SARS-COV-2 Infection
• Other Respiratory Viruses
• Perinatal Morbidity
• Infant Morbidity

Interventions

Type	Name	Description
OTHER	Exposures	COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn

Timeline

• Start date: 2023-12-26
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2023-12-13
• Last updated: 2025-11-28

Locations

2 sites across 2 countries: United States, India