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BACKGROUND: Pregnant women are the highest priority group for annual influenza vaccination. Studies have shown unacceptably low uptake of both seasonal and pandemic A/H1N1 influenza vaccination among pregnant women. This paper will describe the study protocol and methodology of a randomised controlled trial designed to assess the effectiveness of a brief educational intervention in improving the uptake of seasonal influenza vaccine among pregnant women in Hong Kong. METHODS: A randomised controlled trial will be conducted with pregnant women in at least the second trimester of pregnancy from four publicly funded hospital antenatal clinics in Hong Kong. Participants will be randomly assigned to either one of the two treatment groups: standard care (control) or standard care plus brief education (intervention). Pregnant women in the standard care group will receive the usual antenatal care with an educational pamphlet developed by the Hong Kong Centre for Health Protection and those in the intervention group will be provided with usual care plus a brief ten-minute education intervention. Content of the education session will cover four core components recommended in the research literature. The primary study outcome will be the proportion of participants who have received influenza vaccine during their pregnancy. A total of 184 pregnant women (92 per group) will be required to give an 80% power to detect a treatment effect of 15%. DISCUSSION: Most intervention studies aimed at improving influenza vaccination rates in pregnant women have targeted obstetric-care providers and the results of the two patient-oriented RCT interventions are conflicting. The high priority for vaccination given to pregnant women and the low influenza vaccination rate among pregnant women worldwide strongly indicates a need for interventions to improve uptake.
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