| Methods |
Retrospective cohort assessing the safety of pandemic monovalent H1N1 vaccine in pregnant women, using Ontario’s birth record database |
| Participants |
Women with singleton birth in 2009 to 2010 season (n = 55,570) |
| Interventions |
Monovalent pandemic H1N1 influenza vaccine. In all, 23,340 pregnant women were also immunised with seasonal vaccine. |
| Outcomes |
Frequency of neonatal outcomes in newborns:
Preterm birth (< 37 weeks or < 32 weeks) Small for gestational age (below 10th or 3rd percentile) 5‐minute Apgar score below 7 Foetal death
|
| Notes |
"This study was funded by the Canadian Institutes of Health Research (grant 218653)" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| PCS/RCS ‐ selection exposed cohort
All outcomes |
Low risk |
|
| PCS/RCS ‐ selection non‐exposed cohort
All outcomes |
Low risk |
|
| PCS/RCS ‐ comparability
All outcomes |
High risk |
|
| PCS/RCS ‐ assessment of outcome
All outcomes |
Low risk |
|
| Summary assessment |
High risk |
|
