Rosuvastatin for Improving Fetal Growth Restriction in Pregnant Women: A Double-Blind Randomized Clinical Trial

Fetal growth restriction (FGR) results from uteroplacental insufficiency and currently lacks an absolute cure. Statins may offer therapeutic potential by addressing this insufficiency. This study aimed to investigate the effectiveness of rosuvastatin in improving the perinatal outcomes in FGR pregnancies.

A double-blind, randomized placebo-controlled clinical trial was conducted on 78 FGR pregnancies referred to tertiary centers affiliated with Shiraz University of Medical Sciences (Shiraz, Iran) from January 21, 2023, to March 21, 2023. The participants were randomly divided into two groups using the block randomization method to receive either 5 mg rosuvastatin or placebo daily from FGR diagnosis until delivery. Evaluated outcomes included birth weight, umbilical artery pulsatile index reduction, fetal weight gain, vaginal delivery rate, preterm birth (PTB) incidence, 5-min Apgar score <7, neonatal death, neonatal intensive care unit admission, intraventricular hemorrhage, respiratory distress syndrome, necrotizing enterocolitis, and preeclampsia. The data were analyzed using regression models, reporting mean difference (95% CI), frequency (relative frequency), and odds ratio with 95% confidence interval (OR [95% CI]). Statistical significance was set at P<0.05.

The study included 34 subjects in the rosuvastatin group and 44 subjects in the placebo group, with no significant differences in baseline characteristics. However, the rosuvastatin group showed significantly better outcomes in birth weight (276.27 g, 95% CI=32.61-519.93, OR=1.002, 95% CI=1-1.003), umbilical artery pulsatililty index reduction (0.21 g, 95% CI=0.00-0.43, OR=6.600, 95% CI=1.680-25.930), fetal weight gain (312.51 g, 95% CI=90.50-534.52, OR=1.001, 95% CI=1-1.002), and vaginal delivery rate (6/34 [17.6%] vs. 1/44 [2.3%]; OR=9.210, 95% CI=1.050-80.680). Additionally, the rosuvastatin group had significantly lower PTB rates (15/34 [44.10%] vs. 30/44 [68.20%]; OR=0.370, 95% CI=0.150-0.930). Neonatal health status showed no significant differences between groups.

Rosuvastatin demonstrated improved perinatal outcomes in FGR pregnancies without adverse neonatal effects.Trial Registration Number: IRCT20140317017035N8.