RecruitingNCT06168019

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

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

Sponsor

Boston University

Enrollment

10,000 participants

Start Date

Dec 26, 2023

Study Type

OBSERVATIONAL

Conditions

COVID-19 Influenza

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria10

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

Exclusion Criteria2

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).

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