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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 is a clinical trial that has completed, run by ModernaTX. The registered enrollment target is 1,192 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06369272
The ClinicalTrials.gov registry entry for NCT06369272 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT06369272 reports 0 study locations.
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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