Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 300,000
- 主要终点
- Risk of poor health outcomes in neonates
研究概览
简要总结
This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.
详细描述
The Korean National Immunization Program (NIP) first introduced quadrivalent influenza immunization for all pregnant women in the 2020-2021 season. This nationwide cohort study is proposed to assess the risks of adverse maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy. We will use the national health insurance database from the National Health Insurance Service (NHIS) linked with the national immunization program registry data from the Korea Centers for Diseases Control & Prevention (KCDC).
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
- 20 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between September 22, 2020, and April 30, 2021.
排除标准
- •Women aged <20 or >45 years
- •Pregnancies with a chromosomal abnormality
- •Pregnancies with exposure to a known teratogenic medication
结局指标
主要结局
Risk of poor health outcomes in neonates
时间窗: from delivery up to 1 year after birth
Respiratory distress, neonatal intensive care unit admission, and hospital visits with neonatal infection or fever, which are confirmed by diagnosis and healthcare utilization records in the NHIS database.
Risk of adverse pregnancy outcomes
时间窗: from delivery up to 1 year after birth
Spontaneous abortion, stillbirth, neonatal death, congenital anomaly, pre-term birth, fetal growth restriction, small for gestational age, and low birth weight, which are confirmed by diagnostic records in the NHIS database.
Risk of vaccine-related adverse events
时间窗: from delivery up to 1 year after birth
Vaccine-related adverse events confirmed by diagnostic records in the NHIS database.
Risk of poor health outcomes in pregnant women
时间窗: from delivery up to 1 year after birth
Hospital admission, emergency department visits, influenza infection, and hospitalization with influenza infection, which are confirmed by diagnosis and healthcare utilization records in the NHIS database.
次要结局
- Risk of pregnancy-related complications(from delivery up to 1 year after birth)
研究者
Ju-Young Shin
Associate Professor
Sungkyunkwan University