Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369272
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-12
Brief Title:
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
Sponsor:
ModernaTX Inc
Organization:
ModernaTX Inc
Study Overview
Official Title:
An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None