NCT06168019 Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
| NCT ID | NCT06168019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University |
| Condition | Influenza |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2023-12-26 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2023-12-26 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: 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 Criteria: * 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).
Contact & Investigator
Patricia Hibberd, MD PhD
PRINCIPAL INVESTIGATOR
Boston University School of Public Health, Global Health
Frequently Asked Questions
Who can join the NCT06168019 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Influenza. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06168019 currently recruiting?
Yes, NCT06168019 is actively recruiting participants. Contact the research team at plh0@bu.edu for enrollment information.
Where is the NCT06168019 trial being conducted?
This trial is being conducted at Boston, United States, Nagpur, India.
Who is sponsoring the NCT06168019 clinical trial?
NCT06168019 is sponsored by Boston University. The principal investigator is Patricia Hibberd, MD PhD at Boston University School of Public Health, Global Health. The trial plans to enroll 10,000 participants.