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. 2018 Feb 1;2018(2):CD001269. doi: 10.1002/14651858.CD001269.pub6

pcb Sheffield 2012.

Methods Retrospective cohort study assessing the safety of seasonal influenza vaccination administered during pregnancy, covering 5 subsequent epidemic seasons (from 2003 to 2004 to 2007 to 2008)
Participants Women who delivered and received prenatal care at the Southwestern Medical Center of University of Texas and Parkland Health & Hospital System, Dallas, Texas. In all, 8690 were vaccinated and 76,153 acted as unvaccinated controls.
Interventions Seasonal influenza vaccination was offered to pregnant women from October through March in each season.
Outcomes

  • Estimated gestational age

  • Birth weight

  • Major malformations*

  • Stillbirth*

  • NICU admission*

  • Neonatal death

  • Neonatal pneumonia*

  • Hyperbilirubinaemia


*For these outcomes the authors provided effect estimates considering the trimester of administration.
Notes This study should have been performed without external/private/industry funding.
Government funded
Risk of bias
Bias Authors' judgement Support for judgement
PCS/RCS ‐ selection exposed cohort 
 All outcomes Unclear risk Unclear
PCS/RCS ‐ selection non‐exposed cohort 
 All outcomes Unclear risk Unclear
PCS/RCS ‐ comparability 
 All outcomes High risk  
PCS/RCS ‐ assessment of outcome 
 All outcomes Unclear risk Unclear
Summary assessment High risk