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Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) for COVID-19 (ICOPE Trial)

N/A
Recruiting
Led By Patricia Hibberd, MD PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

ICOPE Trial 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.

Eligible Conditions
  • COVID-19
  • Influenza
  • Coronavirus
  • Respiratory Viruses
  • Perinatal Morbidity
  • Infant Mortality

ICOPE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maternal composite adverse outcome variable
Secondary outcome measures
Perinatal composite adverse outcome variable

ICOPE Trial Design

1Treatment groups
Experimental Treatment
Group I: Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE)Experimental Treatment1 Intervention
Pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India.

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
454 Previous Clinical Trials
9,931,570 Total Patients Enrolled
6 Trials studying COVID-19
103,405 Patients Enrolled for COVID-19
Lata Medical Research Foundation, NagpurOTHER
12 Previous Clinical Trials
139,044 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,664,741 Total Patients Enrolled
12 Trials studying COVID-19
53,586 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6667 spots leftby Jun 2028