NCT06369272

Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,192 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: Female
• Age: 13 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Maternal Outcomes
• Infant Outcomes
• Pregnancy

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: United States