Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
NCT ID: NCT06369272
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1192 participants
OBSERVATIONAL
2023-03-01
2023-10-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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SPIKEVAX Exposed Pregnancy
Cohort includes pregnant women who were vaccinated with SPIKEVAX from last menstrual period (LMP) through the exposure ascertainment period for the outcome of interest.
No interventions assigned to this group
SPIKEVAX Distantly Exposed Pregnancy
Cohort includes pregnant women who were exposed to SPIKEVAX at least 60 days prior to LMP and not exposed to SPIKEVAX or any other COVID-19 vaccine from LMP through the exposure ascertainment period for the outcome of interest.
No interventions assigned to this group
Unvaccinated During Pregnancy
Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest.
No interventions assigned to this group
COVID-19 Infected During Pregnancy
Cohort includes pregnant women not exposed to SPIKEVAX or any other COVID-19 vaccine within 60 days prior to LMP through the exposure ascertainment period for the outcome of interest. These women also had at least one medically attended COVID-19 episode during the exposure ascertainment period outcome of interest.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Continuous enrollment in a health plan contributing to the HealthCare Integrated Research Database℠ (HIRD) database for at least 90 days prior to the estimated LMP.
Exclusion Criteria
* Instances where the outcome of a pregnancy is not documented (e.g., a prenatal care claim is followed by no further documentation of pregnancy, termination, or delivery where the participant remains enrolled in the health plan) may also be observed. The number of these possibly exposed pregnancies will be tabulated and described; however, they will not be included in the descriptive or comparative analyses.
13 Years
49 Years
FEMALE
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Carelon Research
Newton, Massachusetts, United States
Countries
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Other Identifiers
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mRNA-1273-P919
Identifier Type: -
Identifier Source: org_study_id
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