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| ID | Type | Description | Link |
|---|---|---|---|
| UG1HD078439 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Lata Medical Research Foundation, Nagpur | OTHER |
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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.
All pregnant women enrolled in the study will receive standard of care throughout their pregnancy, labor and delivery and post-partum to discharge. Wherever possible, study visits will coincide with regular antenatal (ANC) care and blood draws will be added to standard blood draws during ANC, labor and delivery and postpartum care. Women will be counselled about procedure to reduce the risk of acquiring ORV during pregnancy. Since this study is observational, we do not anticipate any specific safety concerns with study interviews and procedures, but the investigators will monitor potential adverse events to determine if they are likely or possibly study related.
PRIMARY OBJECTIVE: Determine the prevalence, incidence, and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 42 postpartum/after miscarriage on maternal outcomes. Secondary analysis will evaluate whether influenza/Other Respiratory Viruses (ORV) infection or COVID-19 vaccination modifies or mediates this risk.
SECONDARY OBJECTIVE: Determine the effect of maternal COVID-19 infection on the fetus and/or neonate during pregnancy through day 7 of life. Secondary analysis will focus on whether influenza/ORV or vaccination modifies, and pre-term birth mediates this risk.
EXPLORATORY OBJECTIVE: Characterize patterns and trajectories of host response/ inflammatory biomarkers as potential mediators of COVID-19 ± Influenza and ORV infection on progression to severe illness in pregnant women/mothers admitted to Government Medical College hospital with COVID-19. Modifiers include COVID-19 , Influenza and other ORV vaccinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) | Pregnant women in their first trimester of pregnancy who present to the outpatient antenatal care clinic at Government Medical College Hospital in Nagpur, India. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposures | Other | COVID-19, Influenza and ORV impact on the pregnant woman, her fetus and newborn |
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| Measure | Description | Time Frame |
|---|---|---|
| Maternal composite adverse outcome variable | The maternal composite variable includes any of following 3 outcomes:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Perinatal composite adverse outcome variable | The perinatal adverse outcomes includes any of the following 3 outcomes:
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Inclusion Criteria:
Women aged 18 to 50 years registering for antenatal care (ANC) at Government Medical College Hospital (GMC) Nagpur, India
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Hibberd, MD PhD | Contact | 617-358-2046 | plh0@bu.edu | |
| Aboli Goghari, MPH | Contact | 617-358-2310 | agoghari@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Hibberd, MD PhD | Boston University School of Public Health, Global Health | Principal Investigator |
| Archana Patel, MD | Lata Medical Research Foundation, Nagpur India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University School of Public Health, Global Health | Recruiting | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Blood samples for COVID-19, influenza and ORV antibodies and potential modifiers of infection will be drawn at a maximum of four time points - baseline (week 6-13 of pregnancy), at study visit 3 (week 28-34), at study visit 4 (week 37-prior to delivery) of pregnancy and between delivery and day 42-70 postpartum/after miscarriage. In addition a random subset of 200 subjects will be invited to provide nasopharyngeal (NP)swabs during all 4 study visits and between delivery and day 7 postpartum (prior to discharge) to track asymptomatic viral infection.
| 1 year |
| Government. Medical College Hospital | Recruiting | Nagpur | India |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |