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NCT06369272 · ClinicalTrials.gov registry record
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
A clinical trial, sponsored by ModernaTX.
- Completed
- Registry status
- 1,192
- Enrollment target
NCT06369272: Completed study, sponsored by ModernaTX.
NCT06369272 is a clinical trial that has completed, run by ModernaTX. The registered enrollment target is 1,192 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06369272 has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- 1,192 participants
- Enrollment target
Study Summary
The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: * If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs). * If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19). * In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders \[e.g., pre-eclampsia, eclampsia, and gestational hypertension\] gestational diabetes, and post-partum hemorrhage; and * To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,192 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2023-10-20 |
What the finished NCT06369272 record still lists
NCT06369272 is an observational study that tracks outcomes without assigning an intervention. Its 1,192 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT06369272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06369272 about?
NCT06369272 is a clinical study titled "Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy". The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: * If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs). * If exposure to SPIKEVAX during pregnancy is associa...
What is the current status of trial NCT06369272?
This trial is currently completed. The enrollment target is 1,192 participants. The study started on 2023-03-01. Estimated completion is 2023-10-20.
Who is sponsoring clinical trial NCT06369272?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
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