pbb Irving 2013.
Methods | Case‐control study investigating the association between influenza immunisation during pregnancy and spontaneous abortion | |
Participants | Cases (n = 243) were identified from among the members of 6 Vaccine Safety Datalink organisations. Diagnoses of spontaneous abortion (ICD‐9 code 634) and unspecified abortion (ICD‐9 codes 637) assigned during the 2005 to 2006 and 2006 to 2007 seasons were reviewed and different diagnoses excluded. Controls (n = 243) were selected from among women who had confirmed intrauterine pregnancy and delivery after the 20th gestational week by frequency‐matching of last menstrual period (within 2 weeks) and healthcare organisation. |
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Interventions | Immunisation with influenza vaccine. Participants were considered exposed if they were immunised within 28 days before index date. Analysis considering whether vaccine exposure occurred during or before pregnancy was also performed. | |
Outcomes | Spontaneous abortion cases | |
Notes | Government funded | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
CC ‐ case selection All outcomes | Low risk | Consecutive series of cases from electronic databases |
CC ‐ control selection All outcomes | Low risk | From the same population |
CC ‐ comparability All outcomes | Unclear risk | Matched by LMP ‐ confounders |
CC ‐ exposure All outcomes | Unclear risk | Medical record |
Summary assessment | Unclear risk | Unclear |