To re-evaluate the systematic evaluation and meta-analysis of safety of statins in pregnancy and provide reference for the safe use of statins in pregnant women.

The systematic reviews/meta-analysis on the safety of statins during pregnancy were retrieved from databases (up to October 8, 2023). The preferred reporting items for systematic reviews and meta-analyse (PRISMA) were used to evaluate the quality of the included literature, a measure tool to assess systematic reviews 2 (AMSTAR 2) scale was used to evaluate the methodological quality of the included literature, and the grading of recommendations assessment, development, and evaluation (GRADE) tool was used to evaluate the evidence quality of the included literature. The results of quantitative analysis of outcome indicators were expressed by relative risk, odds ratio, mean difference and their 95% confidence interval.

A total of 12 systematic reviews/meta-analysis were included. There were 5, 4 and 3 documents with high quality, medium quality, and low quality, respectively, which were evaluated by PRISMA. There were 2 and 10 documents with high and very low quality, which were evaluated by AMSTAR 2 scale. The GRADE tool evidence quality evaluation results showed that among the 48 evidence bodies, 4 were of intermediate quality (8.3%), 37 were of low quality (77.1%), and 7 were of very low quality (14.6%). The re-evaluation results of systematic review/meta-analysis showed that statins exposure during pregnancy did not increase the risk of fetal birth defects and premature delivery, but increased the risk of spontaneous abortion. Pravastatin might reduce the incidence of preeclampsia with uteroplacental insufficiency and neonatal intensive care unit occupancy in patients. There were inconsistent results of statin exposure on fetal cardiac abnormalities and the risk of artificial abortion.

Statins exposure during pregnancy does not increase the risks of fetal birth defects and premature birth, but increases the risk of spontaneous abortion.

Pregnancy outcome; Statins; Safety; Meta-analysis; System evaluation; Re-evaluation