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NCT06168019 · ClinicalTrials.gov registry record
Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India
A clinical trial of COVID-19 and Influenza, sponsored by Boston University.
- Recruiting
- Registry status
- 10,000
- Enrollment target
- 2
- Study locations
NCT06168019: Recruiting study of COVID-19 and Influenza, sponsored by Boston University.
NCT06168019 is a study of COVID-19 and Influenza that is actively recruiting participants, run by Boston University. The registered enrollment target is 10,000 participants, below the 38,431-participant average among 298 other COVID-19 trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06168019, a study of COVID-19 and Influenza, is actively recruiting participants, sponsored by Boston University.
- RECRUITING
- Registry status
- 10,000 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The maternal composite variable includes any of following 3 outcomes: * Preterm labour, defined as hospitalization for the management of onset of labor before fetus age 37 weeks, regardless of when birth occurs; * Pre-eclampsia with severe features, defined as the new onset of systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>110 mm Hg and proteinuria (World Health Organization (WHO) definition); * Mortality at any time between enrolment and day 42 post-partum/after miscarri
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 |
What NCT06168019 shows while recruiting
NCT06168019 is an observational study that tracks outcomes without assigning an intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus, below the 38,431-participant average among 298 other COVID-19 trials with a reported enrollment target (74% lower).
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.
NCT06168019 reports a single indexed study location in Massachusetts, Other.
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.
What interventions are being tested in trial NCT06168019?
The interventions under investigation include: Exposures (OTHER).
Who is sponsoring clinical trial NCT06168019?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06168019's enrollment target sits among peer trials
10,000 25th of 298 higher than 274 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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