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NCT04826640 · ClinicalTrials.gov registry record
Observational Maternal COVID-19 Vaccination Study
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 146
- Enrollment target
NCT04826640 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 146 participants.
The verdict
NCT04826640 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 146 participants
- Enrollment target
Study Summary
This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following the second vaccination using either identical web-based or paper diaries, depending on study participant preference. Maternal serum samples will be collected for antibody titers relevant to COVID-19 at time points that include: prior to vaccination, \~29 days post second vaccination, and at delivery. At Duke University, maternal and infant cord blood will be collected at delivery and analyzed for the same antibody titers. At other clinical sites, these delivery samples will only be collected if feasible. Pregnant women will be followed through 90 days postpartum. with comprehensive obstetric and neonatal outcomes obtained from medical record review.
Interventions
- OTHER Observational
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2021-05-24 |
| Est. Completion | 2023-11-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04826640
The ClinicalTrials.gov registry entry for NCT04826640 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Observational is the first listed.
NCT04826640 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04826640 about?
NCT04826640 is a clinical study titled "Observational Maternal COVID-19 Vaccination Study". This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following the second vaccination using either identical web-based or p...
What is the current status of trial NCT04826640?
This trial is currently completed. The enrollment target is 146 participants. The study started on 2021-05-24. Estimated completion is 2023-11-13.
What interventions are being tested in trial NCT04826640?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT04826640?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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