Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

Sungkyunkwan University300,000 enrolled

Overview

This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.

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).

Study Type

OBSERVATIONAL

Enrollment

300,000

Conditions

Interventions

influenza vaccineBIOLOGICAL

quadrivalent influenza vaccination in the flu seasons

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 adverse pregnancy outcomes

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.