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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT06168019
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Exposures — OTHER
    COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn

Study Details

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.

Key Dates

Start date
Dec 26, 2023
Status verified
Nov 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE)
    Pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India.

Primary Outcome Measure

Maternal composite adverse outcome variable [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston University School of Public Health, Global HealthBostonMassachusetts02118
Patricia Hibberd, MD PhD
[email protected]
Aboli Goghari, MPH
[email protected]

Find similar trials in Boston, MA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Boston University School of Public Health, Global Health· Boston, MA

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