OBJECTIVES: This study aims at evaluating the benefits and harms of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine (HBVac) in preventing mother to child transmission in HBsAg-positive pregnant women during antenatal period. METHODS: Seven databases and three clinical trial registry platforms were searched from inception date to December 2017. Randomized controlled trials (RCTs) were included in this study. The Cochrane risk of bias tool was used to assess the risk of bias of the trials. The main outcomes were analyzed by Review Manager 5.3 software. RESULTS: Sixteen RCTs involving 2440 HBsAg-positive pregnant women were included in the meta-analysis. As for HBIG and HBVac versus no treatment, the number of newborns who were HBsAg-positive [RR: 0.2, 95% CI (0.18, 0.40), P