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Clinical trialNCT06168019RecruitingObservational

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

SponsorBoston UniversityEnrollment10,000COVID-19Infant MorbidityInfluenzaOther Respiratory VirusesPerinatal MorbiditySARS-COV-2 Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Archana Patel, MD

    Lata Medical Research Foundation, Nagpur India

    Principal Investigator
  • Patricia Hibberd, MD PhD

    Boston University School of Public Health, Global Health

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

India
  • Government. Medical College Hospital

    Nagpur, India

    Recruiting
United States
  • Boston University School of Public Health, Global Health

    Boston, Massachusetts, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
26 Dec 2023
Primary completion
30 Jun 2028
Completion
30 Jun 2028
Last update posted
28 Nov 2025
Registered enrollment
10,000
Registry id
NCT06168019

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.