Neurodevelopmental outcomes of children whose mothers were randomized to low-dose aspirin in early pregnancy

Guidelines recommend prescribing low-dose aspirin (LDA) to at-risk pregnant women for the prevention of preeclampsia; however, the impact of antenatal LDA on neurodevelopment is limited. We therefore sought to determine if there were differences in neurodevelopment in children whose mothers had been antenatally randomized to LDA or a placebo. We performed a non-inferiority masked neurodevelopmental follow-up study of a randomly selected subset of children between 33 and 39 months of age in five Low-Middle Income Countries whose mothers had participated in a randomized trial of daily LDA (81mg) or an identical placebo, initiated between 6 weeks and 0 days and 13 weeks and 6 days of pregnancy. LDA was continued to 36 weeks of gestation or birth if it occurred earlier. Children were excluded if they had a significant congenital anomaly that would preclude testing. Children were evaluated using the Bayley Scale of Infant Development-III (BSID-III) and the Ages and Stages Questionnaire 3rd Edition (ASQ-3). Our primary outcome was the cognitive composite score of the BSID-III with the threshold of non-inferiority being defined as a ≥ 4-point difference. A total of 644 children (330 LDA and 314 placebo) were evaluated. Maternal and delivery characteristics did not differ between the two groups (table 1). The cognitive composite score of the BSID-III was non-inferior and did not differ between the two groups (LDA 96± 10 SD vs. Placebo 97± 10, p=0.25). No differences were seen in the BSID-III language composite score (LDA 101± 13 SD vs. Placebo 100± 14, p=0.38) or BSID-III the motor composite score (LDA 99± 13 SD vs. Placebo 100± 14, p=0.50). No differences in the communication, gross motor, fine motor, problem solving and personal-social components of the ASQ-3 were detected. Breastfeeding rates, breastfeeding duration, maternal education, and home environment as measured by the Family Care Indicators did not differ between the two groups. Antenatal LDA exposure beginning as early 6 weeks gestation is not associated with neurodevelopmental delay at 33 to 39 months of age.View Large Image Figure ViewerDownload Hi-res image Download (PPT)