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Influenza and COVID study in pregnant women and their newborn

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048428
Enrollment
10000
Registered
2022-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J100- Influenza due to other identifiedinfluenza virus with pneumonia

Interventions

None listed

Sponsors

National Institute of Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eligibility Criteria : 1. Women ages 18 to 50 years registering for ANC at GMC Hospital Nagpur; 2. Intending to be followed throughout pregnancy, labor and delivery and neonatal care at GMC; 3. Living within the city limits of Nagpur to facilitate access to GMC for evaluation of ILI and COVID symptoms; 4. Estimated Gestational Age at registration 5. Willing to be contacted two times per week by call or text for ILI/COVID symptom screening and return to GMC for an NP swab/evaluation if symptoms are reported; 6. Willing to take temperature with the provided digital thermometer, after training; 7. Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC; 8. Willing to permit blood draws or finger sticks for DBS at all ANC visits and if symptoms occur through day 7 postpartum and during visits to GMC or admission for respiratory illness; 9. Willing to consent.

Exclusion criteria

Exclusion criteria: 1. All those do not meet eligibility criteria and not willing to consent

Design outcomes

Primary

MeasureTime frame
Prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant womenTimepoint: Day 7, post-partum

Secondary

MeasureTime frame
Characterize patterns and trajectories of host response/inflammatory biomarkers as potential mediators of COVID-19±ORV infection on progression to severe illness in pregnant women/mothers admitted with COVID-19Timepoint: Endline;Effect of maternal COVID-19 infection on the fetus and/or neonateTimepoint: Day 7, Post-partum

Countries

India

Contacts

Public ContactDr Archana Patel

Lata Medical Research Foundation

dr_apatel@yahoo.com07122249569

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026