protocolSection identificationModule nctId: NCT06369272, orgStudyIdInfo id: mRNA-1273-P919, briefTitle: Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2023-10-20, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: ModernaTX, Inc., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Maternal Outcomes, conditions: Infant Outcomes, conditions: Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1192, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of MCMs, primaryOutcomes measure: Number of Adverse Neonatal and Infant Outcomes, primaryOutcomes measure: Number of Participants with Hypertensive Disorders, primaryOutcomes measure: Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions, secondaryOutcomes measure: Demographics: Participant Region of Residence, secondaryOutcomes measure: Demographics: Age at LMP, secondaryOutcomes measure: Demographics: Number of Overweight or Obese Participants, secondaryOutcomes measure: Demographics: Duration of Health Plan Enrolment Prior to Pregnancy, secondaryOutcomes measure: Demographics: Calendar Date of the Pregnancy Outcome, secondaryOutcomes measure: Demographics: Participant Race and Ethnicity, secondaryOutcomes measure: Demographics: Participant Socio-economic Status, secondaryOutcomes measure: Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations, secondaryOutcomes measure: Healthcare Utilization: Number of Distinct Medications Used, eligibilityModule sex: FEMALE, minimumAge: 13 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Carelon Research, city: Newton, state: Massachusetts, zip: 02458, country: United States, geoPoint lat: 42.33704, lon: -71.20922, hasResults: False