Study of Influenza and COVID-19 Impact on Pregnant Women and Babies in India Observing Pregnancy Outcomes and Infection Risks At Government Medical College Hospital, Nagpur

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.

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