Actively Recruiting
Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India
Led by Boston University · Updated on 2025-11-28
10000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational study focusing on pregnant women in their first trimester at Government Medical College Hospital, Nagpur, India. The study aims to understand how co-infections with respiratory viruses like COVID-19 and Influenza may increase the risk of negative outcomes for mothers and babies. The study also considers how vaccination against these viruses before or during pregnancy might affect these risks, addressing current care practices in India. All pregnant participants will receive the usual medical care during pregnancy, labor, delivery, and postpartum. Study visits will align with regular antenatal care appointments, adding blood draws and symptom monitoring to standard procedures. Women will receive counseling to reduce respiratory virus infection risks during pregnancy. The study is observational and includes monitoring for any adverse events related to study activities. Participants will be followed through pregnancy and up to 42 days postpartum, with blood samples collected at four key points including baseline, late pregnancy, and after delivery. Researchers will track symptoms of respiratory illness, use symptom diaries and temperature checks, and gather pregnancy and neonatal outcome information. The primary outcome is a composite measure of adverse maternal events within one year, with secondary outcomes focusing on perinatal adverse events and the impact of infections or vaccination.
CONDITIONS
Brief Title
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 50 years registering for antenatal care at Government Medical College Hospital, Nagpur
- Estimated gestational age less than 14 weeks based on ultrasound at baseline visit
- Intends to receive pregnancy, labor, delivery, and neonatal care at Government Medical College Hospital
- Plans to live within Nagpur city limits throughout pregnancy and delivery
- Willing to be contacted twice weekly for symptom screening and return for evaluation if symptoms occur
- Willing to take temperature with provided digital thermometer and maintain a symptom diary
- Willing to provide pregnancy and neonatal outcome information if care occurs outside the hospital
- Willing to allow venous blood draws at baseline, 28-34 weeks, 37 weeks prior to delivery, and after delivery
- Willing to allow blood draws if hospitalized for COVID-19 infection
- Willing to provide informed consent to participate
You will not qualify if you...
- Limited decision-making capacity due to substantial impairment of cognitive function
- Limited ability to provide legally effective consent as defined by Boston University Institutional Review Board
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to delivery and 42 days postpartum
Participants are observed through pregnancy, labor, delivery, and postpartum using regular antenatal care visits. Blood draws and symptom screening are incorporated during routine care to monitor COVID-19, Influenza, and other respiratory virus exposures and outcomes.
Visits coincide with regular antenatal care and postpartum visits; blood draws at baseline, 28-34 weeks, 37 weeks prior to delivery, and after delivery; twice-weekly symptom screenings
Trial Site Locations
Total: 2 locations
1
Boston University School of Public Health, Global Health
Boston, Massachusetts, United States, 02118
Actively Recruiting
2
Government. Medical College Hospital
Nagpur, India
Actively Recruiting
Research Team
P
Patricia Hibberd, MD PhD
A
Aboli Goghari, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here