Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Sungkyunkwan University
- Enrollment
- 300000
- Primary Endpoint
- Risk of poor health outcomes in neonates
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.
Detailed Description
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).
Investigators
Ju-Young Shin
Associate Professor
Sungkyunkwan University
Eligibility Criteria
Inclusion Criteria
- •Pregnant women between September 22, 2020, and April 30, 2021.
Exclusion Criteria
- •Women aged \<20 or \>45 years
- •Pregnancies with a chromosomal abnormality
- •Pregnancies with exposure to a known teratogenic medication
Outcomes
Primary Outcomes
Risk of poor health outcomes in neonates
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Risk of pregnancy-related complications(from delivery up to 1 year after birth)