Incidence and predictors of elevated postpartum alanine aminotransferase in chronic hepatitis B mothers

Abstract

Abstract Background The majority of HBeAg-positive mothers with chronic hepatitis B have high levels of viremia and inactive disease with normal alanine aminotransferase (ALT) during pregnancy. In addition, postpartum disease activation and ALT flare have been reported in the range of 15% − 35%. However, the current International Association Guidelines have not provided clear recommendations and a risk-stratified monitoring schedule. Furthermore, data are lacking on the definition of normal ALT in the postpartum period in mothers with chronic hepatitis B. The clinical features and ALT flare patterns in HBeAg-positive mothers versus HBeAg-negative mothers are not fully explored. Thus, we design a cohort study to investigate the aforementioned area and generate data to assist healthcare providers in the better management of mothers with hepatitis B. Method This study is a single-center and prospective cohort study (n = 360) that consists of two groups of patients including HBsAg-positive mothers (n = 120) and healthy mothers without HBV infections (n = 240). In HBeAg-positive mothers, antiviral therapy during late pregnancy is permitted for the prevention of MTCT but discontinued at delivery if no further indication for the treatment. Mothers are enrolled at the gestational weeks of 12–24. After delivery, both mothers and their infants will be followed up until postpartum week 24. Clinical and laboratory data are collected every 4 weeks during the study except there are no follow-up visits at the postpartum weeks 16 and 20. The primary assessment is the proportion of patients with postpartum ALT flares. The secondary assessments are independent risk factors during pregnancy for predicting postpartum ALT flares and the normal range of postpartum ALT levels in healthy mothers. Discussion We will assess the incidence of postpartum ALT flares in mothers with chronic hepatitis B with subgroup analysis based on HBeAg status, and evaluate the normal range of postpartum ALT in healthy mothers without hepatitis B. In mothers with hepatitis B, the independent risk factors for predicting postpartum ALT flares are also investigated. Trial Registration Number at the Chinese Clinical Trial Registry: ChiCTR2200061130