Clinical trial NCT06369272: Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
Official title: An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Outcomes
Infant Outcomes
Pregnancy
Keywords: Maternal outcomes
Infant outcomes
Pregnancy
Observational
SPIKEVAX
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 1192
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes women for whom an LMP can be successfully calculated based on a non-missing end of pregnancy (EOP), and who also meet the eligibility criteria to be included in the study analyses.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of MCMs
timeFrame: Up to approximately 3 years
measure: Number of Adverse Neonatal and Infant Outcomes
timeFrame: Up to approximately 3 years
measure: Number of Participants with Hypertensive Disorders
timeFrame: Up to approximately 3 years
measure: Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Demographics: Participant Region of Residence
timeFrame: Baseline
measure: Demographics: Age at LMP
timeFrame: Baseline
measure: Demographics: Number of Overweight or Obese Participants
timeFrame: Baseline
measure: Demographics: Duration of Health Plan Enrolment Prior to Pregnancy
timeFrame: Baseline
measure: Demographics: Calendar Date of the Pregnancy Outcome
timeFrame: Baseline
measure: Demographics: Participant Race and Ethnicity
timeFrame: Baseline
measure: Demographics: Participant Socio-economic Status
timeFrame: Baseline
measure: Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations
timeFrame: Baseline
measure: Healthcare Utilization: Number of Distinct Medications Used
timeFrame: Baseline
Other outcomes:
Locations:
city: Newton
country: United States
facility: Carelon Research
state: Massachusetts
Study officials:
References: