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Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
NCT06168019 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Exposures
Study Locations (2)
Massachusetts
- Boston University School of Public Health, Global Health — Boston
Other
- Government. Medical College Hospital — Nagpur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2023-12-26 |
| Est. Completion | 2028-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06168019
The ClinicalTrials.gov registry entry for NCT06168019 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 150 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention — of which Exposures is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06168019 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06168019 about?
NCT06168019 is a clinical study titled "Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India". 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 obs...
What is the current status of trial NCT06168019?
This trial is currently recruiting. The enrollment target is 10,000 participants. The study started on 2023-12-26. Estimated completion is 2028-06.
What conditions does trial NCT06168019 study?
This clinical trial studies the following conditions: COVID-19, Influenza, SARS-COV-2 Infection, Infant Morbidity, Other Respiratory Viruses. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06168019?
The interventions under investigation include: Exposures (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06168019?
This trial is sponsored by Boston University, which has 150 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06168019 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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