Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy

Matthew K. Hoffman, Shivaprasad Goudar, Sangappa Dhaded, Lester Figueroa, Manolo Mazariegos, Nancy F. Krebs, Jamie Westcott, Shiyam Sunder Tikmani, Fatima Karim, Sarah Saleem, Robert L. Goldenberg, Adrien Lokangaka, Antoinette Tshefu, Melissa Bauserman, Archana Patel, Prabir Das, Patricia Hibberd, Elwyn Chomba, Musaku Mwenchanya, Waldemar A. CarloMarissa Trotta, Alexis Williams, Janet Moore, Tracy Nolen, Norman Goco, Elizabeth M. McClure, Michele A. Lobo, Andrea B. Cunha, Richard J. Derman

Research output: Contribution to journalArticlepeer-review


OBJECTIVE:Because low-dose aspirin is now commonly prescribed in pregnancy, we sought to assess the association between early antenatal exposure and child neurodevelopment.METHODS:We performed a noninferiority, masked, neurodevelopmental follow-up study of children between age 33 and 39 months whose mothers had been randomized to daily low-dose aspirin (81 mg) or placebo between 6 0/7 and 13 6/7 weeks of gestation through 37 weeks. Neurodevelopment was assessed with the Bayley-III (Bayley Scales of Infant and Toddler Development, 3rd Edition) and the ASQ-3 (Ages and Stages Questionnaire, 3rd Edition). The primary outcome was the Bayley-III cognitive composite score with a difference within 4 points demonstrating noninferiority.RESULTS:A total of 640 children (329 in the low-dose aspirin group, 311 in the placebo group) were evaluated between September 2021 and June 2022. The Bayley-III cognitive composite score was noninferior between the two groups (-1, adjusted mean -0.8, 95% CI, -2.2 to 0.60). Significant differences were not seen in the language composite score (difference 0.7, 95% CI, -0.8 to 2.1) or the motor composite score (difference -0.6, 95% CI, -2.5 to 1.2). The proportion of children who had any component of the Bayley-III score lower than 70 did not differ between the two groups. Similarly, the communication, gross motor, fine motor, problem-solving, and personal-social components of the ASQ-3 did not differ between groups. Maternal characteristics, delivery outcomes, breastfeeding rates, breastfeeding duration, and home environment as measured by the Family Care Indicators were similar.CONCLUSION:Antenatal low-dose aspirin exposure was not associated with altered neurodevelopmental outcomes at age 3 years.

Original languageEnglish
Pages (from-to)554-561
Number of pages8
JournalObstetrics and Gynecology
Issue number4
Publication statusPublished - 1 Apr 2024
Externally publishedYes


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