RecruitingNCT06168019

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

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


Sponsor

Boston University

Enrollment

10,000 participants

Start Date

Dec 26, 2023

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Exposures for people with covid-19, infant morbidity, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years to 50 Years.

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

OTHERExposures

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

View Full Details on ClinicalTrials.gov

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NCT06168019


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