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

NCT06168019 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Exposures

COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Lata Medical Research Foundation, Nagpur

    collaborator OTHER

  • Boston University

    lead OTHER

Principal Investigators

  • Patricia Hibberd, MD PhD · Boston University School of Public Health, Global Health

  • Archana Patel, MD · Lata Medical Research Foundation, Nagpur India

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-26
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168019 on ClinicalTrials.gov