Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India
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.
⁃ Women aged 18 to 50 years registering for antenatal care (ANC) at Government Medical College Hospital (GMC) Nagpur, India
• Estimated Gestational Age at registration \<14 weeks based on ultrasound report at the baseline study visit;
• Intends to receive pregnancy, labor and delivery and neonatal care at GMC;
• Plans to live within the city limits of Nagpur throughout their pregnancy and labor and delivery to facilitate access to GMC for evaluation of ILI and COVID-19 symptoms;
• Willing to be contacted two times per week by call or text for ILI/ COVID-19 symptom screening and return to GMC for evaluation and an NP swab/evaluation if symptoms are reported;
• Willing to take temperature with the provided digital thermometer, and maintain a symptom diary after training;
• Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;
• Willing to permit venous blood draws on at least 4 timepoints --1) Baseline study visit, 2)28-34 weeks, 3) 37 weeks - prior to delivery and 4) after delivery;
• Willing to permit blood draws if hospitalized at GMC for COVID-19 infection;
• Willing to consent to participate in the study