NCT06369272已完成不适用
An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,192
- 试验地点
- 1
- 主要终点
- Number of Adverse Neonatal and Infant Outcomes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 13 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Adverse Neonatal and Infant Outcomes
时间窗: 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 Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions
时间窗: Up to approximately 3 years
Number of MCMs
时间窗: Up to approximately 3 years
Number of Participants with Hypertensive Disorders
时间窗: Up to approximately 3 years
Hypertensive disorders include pre-eclampsia, eclampsia, and gestational hypertension, gestational diabetes, or post-partum hemorrhage
次要结局
- Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations(Baseline)
- Demographics: Age at LMP(Baseline)
- Demographics: Participant Socio-economic Status(Baseline)
- Demographics: Participant Region of Residence(Baseline)
- Demographics: Number of Overweight or Obese Participants(Baseline)
- Demographics: Duration of Health Plan Enrolment Prior to Pregnancy(Baseline)
- Demographics: Calendar Date of the Pregnancy Outcome(Baseline)
- Demographics: Participant Race and Ethnicity(Baseline)
- Healthcare Utilization: Number of Distinct Medications Used(Baseline)
研究者
研究点 (1)
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