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• Hepatitis B association with maternal and neonatal complications remains unclear. • Three good quality studies revealed that hepatitis B can cause adverse outcomes. • Larger, more robust, well-designed prospective cohort studies are needed. The association between hepatitis B virus (HBV) infection and maternal, obstetric and newborn outcomes remains controversial, as previous studies have reported conflicting and inconsistent results on the matter. The aim was to investigate whether HBV infection increases the risk of maternal, obstetric and newborn complications. We conducted a systematic literature review, according to PRISMA statement guidelines. Studies were eligible for inclusion if they were observational cohort, case-control or cross-sectional studies, comparing maternal, obstetric or newborn complications in HBV-infected and uninfected pregnant women. PubMed was searched for published literature in English, with no date restrictions, using combinations of keywords. The titles and abstracts were independently screened for eligibility by three authors. Two authors assessed the quality of each included study and no meta-analysis was performed. We retrieved 275 records and included 15 papers. The methodological and statistical heterogeneity as well as a great variation on the types of maternal, obstetric and newborn complications studied did not allow quantitative analysis of results and conclusions about the level of evidence. Seven studies are of good quality, which makes their results more reliable. Three of them revealed that maternal HBV infection increased the risk of miscarriage, preterm birth, pregnancy-induced hypertension, fetal distress and macrosomia. These three studies were performed in China and the one with the largest number of participants only included women from rural areas. Larger, more robust, well-designed prospective cohort studies are needed. These must include adjusted estimates for confounding factors, such as other possible complications determinants, like the antenatal care quality. [ABSTRACT FROM AUTHOR]