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.
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;
Anyone who is deemed to have limited decision-making capacity as defined by Boston University IRB i.e. Substantial impairment of cognitive functions (e.g. attention, comprehension, memory, and intellect), or conditions that might affect their cognitive functions.
Anyone who is deemed to have limited capacity to consent as defined by Boston University Institutional Review Board (IRB) i.e. The ability to provide legally effective consent to enroll in a research study (AAHRPP definition).
The study population is pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India. Women will be aged 18-50 and can be from any race or ethnic group.
Cohort
Prospective
Exposures
Other interventionCOVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn
Maternal composite adverse outcome variable
The maternal composite variable includes any of following 3 outcomes: * Preterm labour, defined as hospitalization for the management of onset of labor before fetus age 37 weeks, regardless of when birth occurs; * Pre-eclampsia with severe features, defined as the new onset of systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>110 mm Hg and proteinuria (World Health Organization (WHO) definition); * Mortality at any time between enrolment and day 42 post-partum/after miscarriage.
Perinatal composite adverse outcome variable
The perinatal adverse outcomes includes any of the following 3 outcomes: * Preterm birth, defined as gestational age of \<37 weeks at birth, based on gestational age dating by ultrasound obtained before study enrolment; * Neonatal critical illness, defined as any sign of critical illness in the newborn and/or continued hospitalization after day 7 of life; * Perinatal Mortality, defined as fetal mortality after week 20 of pregnancy through neonatal death by day 7 of life
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Boston University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Lata Medical Research Foundation, Nagpur
Collaborator
