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RECRUITING
NCT06168019

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

Sponsor: Boston University

View on ClinicalTrials.gov

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

Interventions

OTHER

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