The Pregnancy and Influenza Project: design of an observational case-cohort study to evaluate influenza burden and vaccine effectiveness among pregnant women and their infants.

The US Centers for Disease Control and Prevention is conducting an observational study of 300-500 women infected with influenza during pregnancy. Women are being recruited from members of the Kaiser Permanente health plan in 2 metropolitan areas before and during the 2010 through 2011 influenza season either following routine prenatal care visits or presentation with an acute respiratory infection. All enrolled mothers and their infants will be followed up through 1 month after delivery. Infants of mothers who had influenza during pregnancy and 1000 infants of mothers who were not diagnosed with influenza during pregnancy will be followed up for an additional 5 months. The Pregnancy and Influenza Project is focused on better understanding the burden of influenza during and after pregnancy and estimating the effectiveness of maternal influenza vaccination against influenza among women and their infants confirmed by real-time reverse transcription polymerase chain reaction assays.