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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: Completed study, sponsored by Duke University.
NCT04826640 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 146 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
As measured by the proportion of women experiencing one of the following: Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death.
Interventions
- OTHER Observational
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2021-05-24 |
| Est. Completion | 2023-11-13 |
What the finished NCT04826640 record still lists
NCT04826640 is an observational study that tracks outcomes without assigning an intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Observational is the first listed.
NCT04826640 does not publish any study locations in the registry export this page uses.
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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