Status:
RECRUITING
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
Lead Sponsor:
Boston University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lata Medical Research Foundation, Nagpur
Conditions:
Influenza
COVID-19
Eligibility:
FEMALE
18-50 years
Brief 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 Medic...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06168019
Start Date
December 26 2023
End Date
June 1 2028
Last Update
November 28 2025
Active Locations (2)
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1
Boston University School of Public Health, Global Health
Boston, Massachusetts, United States, 02118
2
Government. Medical College Hospital
Nagpur, India