BACKGROUND: Infant hepatitis B infection increases risk of chronic infection, cirrhosis or liver cancer (hepatocellular carcinoma) in adult. Perinatal transmission is a common route of infection.
OBJECTIVES: To assess the effectiveness and adverse effects of hepatitis B vaccine administered to pregnant women for preventing hepatitis B virus infection in infants.
SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2010).
SELECTION CRITERIA: Randomized controlled trials (RCTs) assessing hepatitis B vaccination compared with placebo or no treatment during pregnancy for preventing infant infection. We excluded quasi-RCTs and crossover studies.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility.
MAIN RESULTS: We were not able to include any studies.
AUTHORS' CONCLUSIONS: We found no RCTs that assessed the effects of hepatitis B vaccine during pregnancy for preventing infant infection. Consequently, this review cannot provide guidance for clinical practice in this area. However, it does identify the need for well-designed randomized clinical trials for the effect of hepatitis B vaccine during pregnancy on the incidence of infant infection and adverse effects.