Abstract
Pre-eclampsia and its related consequences last to be significant factors in maternal morbidity and mortality, particularly in high-risk pregnant women. Aspirin has revealed promise in reducing these risks, particularly when initiated early in gestation. This study evaluated the effectiveness of 75 mg aspirin, started before 12 weeks gestation, in reducing adverse pregnancy outcomes among high-risk women. We achieved a randomized controlled experiment with high-risk pregnant women. Pregnant women were randomly allocated to receive either 75 mg of Aspirin or a placebo. Daily from the point of enrolment. (< 12 weeks gestation) until 36 weeks of gestation or until delivery. Established clinical criteria defined high-risk status. The primary outcome was the pre-eclampsia occurrence. The secondary outcomes encompassed neonatal intensive care unit (NICU) admission, preterm birth, fetal growth restriction (FGR), perinatal mortality, neonatal morbidity, gestational hypertension, and postpartum hemorrhage. Outcomes were analyzed utilizing Chi-square, two-sample z-tests, and Fisher's exact test. This study was approved by the Ethical Committee of the Faculty of Medicine, Beni-Suef University, with approval number FWA00015574. The trial was first registered on ClinicalTrials.gov (Registration number: NCT07087067) on 25/07/2025. The occurrence of pre-eclampsia was markedly reduced in the aspirin group (8.9%) relative to the control group (28.6%) (p = 0.026). Aspirin also significantly reduced rates of FGR (4.4% vs. 19.0%, p = 0.045), NICU admission (8.9% vs. 28.6%, p = 0.026), and composite neonatal morbidity (8.9% vs. 31.0%, p = 0.014). Differences in preterm birth (2.2% vs. 9.5%, p = 0.19) and perinatal death (0% vs. 2.4%, p = 0.48) did not reach statistical significance. No increase in postpartum hemorrhage or maternal complications was noted with aspirin use. Early beginning of 75 mg low-dose aspirin in high-risk pregnant women significantly reduced pre-eclampsia and several adverse neonatal outcomes without increasing maternal risk. These findings support that early initiation of low-dose Aspirin is a secure and efficacious approach for the prevention of pre-eclampsia in pregnant women at elevated risk.