OBJECTIVES: This study aims at evaluating the benefits and harms of hepatitis B immune globulin (HBIG) and hepatitis B vaccine (HBVac) in preventing mother to child transmission in HBsAg positive pregnant women during antenatal period. METHODS: Seven electronic databases and three clinical trial registry platforms were searched from inception date to December 2017. Only randomized controlled trials (RCTs) were included in this study. The Cochrane risk of bias tool was applied to assessing the risk of bias. The outcomes were analyzed by Review Manager 5.3 software. RESULTS: Sixteen RCTs involving 2440 HBsAg positive pregnant women were included in the meta-analysis. Compared to placebo group, HBIG and HBVac group had a significant decrease in the number of newborns who were HBsAg positive [RR: 0.2, 95% CI (0.18, 0.40), P < 0.00001] and HBV-DNA positive [RR: 0.25, 95% CI (0.09, 0.71), P=0.010], and had a significant increase in the number of anti-HBs positive newborns [RR: 3.95, 95% CI (3.11, 5.00), P<0.00001]. After one-year follow up, the number of HBsAg positive newborns continued to decline [RR: 0.09, 95% CI (0.04, 0.20), P<0.00001] and the number of anti-HBs positive newborns continued to increase in HBIG and HBVac group [RR: 1.30, 95% CI (1.22, 1.38), P<0.00001]. Compared to HBIG group, HBIG and HBVac group had no significant difference in the number of HBsAg positive newborns [RR: 1.68, 95% CI (0.66, 4.30), P=0.28], and had a significant decrease in the number of HBsAg positive newborns [RR: 0.31, 95% CI (0.12, 0.84), P=0.02]. Additionally, only 1 study reported 2 swelling cases, 4 studies were reported no adverse events and 11 studies were not report adverse reaction. CONCLUSIONS: HBIG and HBVac could be an effective alternative for HBsAg positive pregnant women to prevent mother to child transmission.