Objective To investigate effect of Sijun Shoutai decoction in improving anemia status of pregnant women with thalassemia, and to guide the Chinese medicine treatment of thalassemia in pregnant women in the future. Methods Two hundred pregnant women with thalassemia who were diagnosed in the hospital from May 2019 to October 2020 were divided into observation group and control group randomly, with 100 cases in each group. The observation group was treated with Sijun Shoutai decoction,1 dose/d, with continuous treatment for 3 months. The control group was given placebo,1 dose/d, with continuous treatment for 3 months. The indicators of blood test [hemoglobin (HGB), red blood cell (RBC), hematocrit value (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH)], TCM symptom scores, hepatic and renal indicators [alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cre), urea (Ure), total bile acid (TBA)] were compared between the two groups before and after treatment for 3 months. The maternal pregnancy outcome and neonatal condition in the two groups were recorded and compared. Results There were no statistical difference in the HGB, RBC, HCT, MCV and MCH between the two groups before treatment (P>0.05); after 3 months the indicators above of two groups increased, and those in observation group were higher than those in control group (P<0.05). There were no statistical differences in the symptom scores of poor appetite, fatigue, abdominal distension after eating or after noon and fecal abnormalities between the two groups before treatment (P<0.05). The levels of ALT, AST and TBA in the two groups decreased after treatment for 3 months, while the Cre and Ure increased, but the differences were not statistically significant (P>0.05). There were no statistical differences in the rates of intrauterine fetal distress, intrauterine growth restriction, and postpartum hemorrhage between the two groups (P>0.05), though the results of observation group were lower than control group.The rate of premature birth was lower than that of control group(P<0.05) ; the gestational week of observation group was more than control group, and the cesarean section rate of observation group was lower than that of control group (P<0.05). There were no statistical differences in the rates of neonatal asphyxia and transfering to PICU between the two groups (P>0.05); the neonatal birth weight and HGB in observation group were higher than those in control group (P<0.05). Conclusion Sijun Shoutai decoction in the treatment of pregnant women with thalassemia can improve anemia status, with no adverse effect on liver or kidney function, improve TCM syndrome, reduce the risk of premature birth,reduce the rate of cesarean,and improve the neonatal condition.