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Previous studies have detected the correlation of polymorphisms in regulatory T cells associated genes  FOXP3  and  CTLA-4  with pre-eclampsia (PE) risk, but the results are inconsistent among studies. Eligible studies were retrieved in several database. Odds ratios (ORs) with 95% confidence intervals (CIs) were utilised to evaluate the relationship between  FOXP3  rs3761548,  FOXP3  rs2232365,  CTLA-4  rs231775 polymorphisms, and PE susceptibility in the genetic models. The subgroup analysis and trial sequential analysis were performed. Twelve studies with a total of 4658 participants were included. There was a statistically significant association between  FOXP3  rs3761548 polymorphism and PE within the recessive model in Asian (OR = 0.54, 95% CI = 0.34–0.86 ) . Trial sequential analysis indicated sufficient proof of such association in the Asian population. This meta-analysis provides sufficient statistical evidence indicating an association between  FOXP3  rs3761548 polymorphism and PE risk in Asian.IMPACT STATEMENTWhat is already known on this subject?FOXP3  and  CTLA4  are markers of regulatory T cells which play a crucial role during a preeclamptic pregnancy.What do the results of this study add?  Eleven studies with a total of 4658 participants were included. There was a statistically significant association between  FOXP3  rs3761548 polymorphism and pre-eclampsia (PE) within the recessive model in Asian (OR = 0.54, 95% CI = 0.34–0.86 ) . Trial sequential analysis indicated sufficient proof of such association in the Asian population. However, there was no enough evidence could proof significant association between  FOXP3  rs2232365 or  CTLA-4  rs231775 polymorphism and PE.What are the implications of these findings for clinical practice and/or further research?  This meta-analysis provides sufficient statistical evidence indicating an association between  FOXP3  rs3761548 polymorphism and PE risk in Asian. The findings in this study may provide a basis for the further study on  FOXP3  rs3761548 polymorphism in future research. What is already known on this subject?FOXP3  and  CTLA4  are markers of regulatory T cells which play a crucial role during a preeclamptic pregnancy. What do the results of this study add?  Eleven studies with a total of 4658 participants were included. There was a statistically significant association between  FOXP3  rs3761548 polymorphism and pre-eclampsia (PE) within the recessive model in Asian (OR = 0.54, 95% CI = 0.34–0.86 ) . Trial sequential analysis indicated sufficient proof of such association in the Asian population. However, there was no enough evidence could proof significant association between  FOXP3  rs2232365 or  CTLA-4  rs231775 polymorphism and PE. What are the implications of these findings for clinical practice and/or further research?  This meta-analysis provides sufficient statistical evidence indicating an association between  FOXP3  rs3761548 polymorphism and PE risk in Asian. The findings in this study may provide a basis for the further study on  FOXP3  rs3761548 polymorphism in future research.

Gene polymorphism associated with FOXP3 , CTLA-4 and susceptibility to pre-eclampsia: a meta-analysis and trial sequential analysis