Actively Recruiting
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Led by Boston University · Updated on 2025-11-28
10000
Participants Needed
2
Research Sites
231 weeks
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
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
Official 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, India
- Estimated gestational age less than 14 weeks based on ultrasound at baseline visit
- Intend to receive pregnancy, labor, delivery, and neonatal care at Government Medical College Hospital
- Plan to live within Nagpur city limits throughout pregnancy and delivery
- Willing to be contacted twice weekly by call or text for symptom screening and return for evaluation if symptoms occur
- Willing to take temperature with provided digital thermometer and maintain a symptom diary after training
- Willing to provide information on pregnancy and neonatal outcomes if care occurs outside the hospital
- Willing to permit venous blood draws at baseline, 28-34 weeks, 37 weeks prior to delivery, and after delivery
- Willing to permit blood draws if hospitalized for COVID-19 infection
- Willing to provide informed consent to participate
You will not qualify if you...
- Having limited decision-making capacity as defined by Boston University IRB due to cognitive impairment
- Having limited capacity to consent as defined by Boston University IRB
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Aboli Goghari, MPH
CONTACT
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
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