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

Pregnancy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06369272
Study type Observational
Source ModernaTX, Inc.
Contact
Status Completed
Phase
Start date March 1, 2023
Completion date October 20, 2023
View Details
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