Infant Outcomes, Maternal Outcomes, Pregnancy
Conditions
Keywords
Maternal outcomes, Infant outcomes, Pregnancy, Observational, SPIKEVAX
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 \[e.g., pre-eclampsia, eclampsia, and gestational hypertension\] 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.
Interventions
None listed
Sponsors
ModernaTX, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* EOP within study period * 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
* Exposure to any non-Moderna COVID-19 vaccines at any time prior to LMP and from LMP through the exposure ascertainment period for the outcome of interest. However, pregnant women exposed to other non-Moderna vaccines in addition to SPIKEVAX will be included in a sensitivity analysis. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions | Up to approximately 3 years | — |
| Number of MCMs | Up to approximately 3 years | — |
| Number of Adverse Neonatal and Infant Outcomes | Up to approximately 3 years | Adverse neonatal and infant outcomes include neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, or incidence of hospitalization due to infections including COVID-19. |
| Number of Participants with Hypertensive Disorders | Up to approximately 3 years | Hypertensive disorders include pre-eclampsia, eclampsia, and gestational hypertension, gestational diabetes, or post-partum hemorrhage |
Secondary
| Measure | Time frame |
|---|---|
| Demographics: Calendar Date of the Pregnancy Outcome | Baseline |
| Demographics: Participant Race and Ethnicity | Baseline |
| Demographics: Participant Region of Residence | Baseline |
| Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations | Baseline |
| Healthcare Utilization: Number of Distinct Medications Used | Baseline |
| Demographics: Participant Socio-economic Status | Baseline |
| Demographics: Age at LMP | Baseline |
| Demographics: Number of Overweight or Obese Participants | Baseline |
| Demographics: Duration of Health Plan Enrolment Prior to Pregnancy | Baseline |
Countries
United States
Outcome results
None listed