Project Details

Neurodevelopmental Follow-up of Children whose Mothers Participated in the ASPIRIN Study

Richard Derman, MD, MPH

Summary

BACKGROUND: Neurodevelopmental delays affect millions of children worldwide, but such delays are more prevalent in low- and middle-income countries (LMICs). The Global Network ASPIRIN Trial is a randomized, placebo-controlled trial implemented in seven LMICs to determine if low dose aspirin (LDA) taken during pregnancy can reduce preterm birth and other pregnancy-related problems that can negatively impact neurodevelopmental status of offspring. GAP: The ASPIRIN Trial demonstrated that LDA administered antenatally decreases the rate of preterm birth, preterm hypertensive disorders of pregnancy, and perinatal mortality. However, a follow-up study is required to determine the impact of antenatal LDA exposure on neurodevelopmental status of offspring when measured at about 3 years of age. HYPOTHESES: Primary Hypothesis: Children exposed antenatally to LDA will have scores on Bayley Scales of Infant Development-III (BSID-III) examination at 36 months of life (+/- 3 months) that are not inferior to their peers who were not exposed; and conditional on showing non-inferiority, children exposed antenatally to low dose aspirin will have higher scores on the BSID-III examination compared to their peers who were not exposed. Secondary Hypothesis: Children exposed antenatally to low dose aspirin will have similar scores on the Ages & Stages-3 Questionnaire (ASQ-3); and conditional on showing non-inferiority, children exposed antenatally to low dose aspirin will have higher scores on this examination compared to their peers who were not exposed. METHODS: A prospective masked matched cohort study will be implemented at 6 LMIC sites to assess neuro-developmental status of 620 ASPIRIN Trial offspring between 33 and 39 months of age who are equally split between a group whose mothers took LDA in the ASPIRIN Trial and a group whose mothers took a placebo. Assessment scores of the two groups will be compared and findings issued for the stated hypotheses. RESULTS: Pending. IMPACT: The study may enlighten governmental policy, parental decision-making and obstetrical counselling. It could encourage scale-up of LDA aspirin use during pregnancy if the LDA exposed children have either higher or non-inferior neurodevelopmental scores compared to the children in the placebo group.

Publications:

Hoffman MK, Goudar S, Dhaded S, Figueroa L, Mazariegos M, Krebs NF, Westcott J, Tikmani SS, Karim F, Saleem S, Goldenberg RL, Lokangaka A, Tshefu A, Bauserman M, Patel A, Das P, Hibberd P, Chomba E, Mwenchanya M, Carlo WA, Trotta M, Williams A, Moore J, Nolen T, Goco N, McClure EM, Lobo MA, Cunha AB, Derman RJ. Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy. Obstet Gynecol. 2024 Jan 23. doi: 10.1097/AOG.0000000000005514. Epub ahead of print. PMID: 38262066.