Author: Petousis-Harris, Helen; Walls, Tony; Watson, Donna; Paynter, Janine; Graham, Patricia; Turner, Nikki
Title: Safety of Tdap vaccine in pregnant women: an observational study Document date: 2016_4_18
ID: 5ztat9cw_8
Snippet: Inclusion criterion was being compliant with routine antenatal care, including at least one ultrasound early in pregnancy. Women who had given birth prior to being contacted by study team members were originally to be excluded from both arms of the study; however, owing to concern that this may lead to overlooked serious adverse events (SAEs; ie, premature birth) early in the study, after the first exclusion, subsequent women in the Northern arm .....
Document: Inclusion criterion was being compliant with routine antenatal care, including at least one ultrasound early in pregnancy. Women who had given birth prior to being contacted by study team members were originally to be excluded from both arms of the study; however, owing to concern that this may lead to overlooked serious adverse events (SAEs; ie, premature birth) early in the study, after the first exclusion, subsequent women in the Northern arm who had birthed prior to contact but met other inclusion criteria were included.
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