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Published on: June 28, 2024
Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy
Matthew K Hoffman1, Shivaprasad Goudar, Sangappa Dhaded
1Christiana Care and the University of Delaware, Newark, Delaware; Jawaharlal Nehru Medical College, KLE University, Belgavi, Lata Medical Research Foundation, Nagpur, and Datta Meghe Institute of Higher Education and Research, Wardha, India; Instituto de Nutrición de Centro América y Panamá, Guatemala; University of Colorado Anschutz Medical Campus, Aurora, Colorado; Aga Khan University, Karachi, Pakistan; Columbia University, New York, New York; Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo; University of North Carolina at Chapel Hill, Chapel Hill, and RTI International, Research Triangle, North Carolina; Boston University School of Public Health, Boston, Massachusetts; University Teaching Hospital, Lusaka, Zambia; University of Alabama at Birmingham, Birmingham, Alabama; University of Nebraska Medical Center, Omaha, Nebraska; and Thomas Jefferson University, Philadelphia, Pennsylvania.
Insights
Early pregnancy aspirin use did not impact child neurodevelopment. This study found no significant differences in cognitive, language, or motor skills at age 3 in children exposed to low-dose aspirin during pregnancy compared to placebo.
Area of Science:
- Obstetrics and Gynecology
- Developmental Pediatrics
- Clinical Pharmacology
Background:
- Low-dose aspirin is frequently prescribed during pregnancy.
- The effects of early antenatal aspirin exposure on child neurodevelopment require thorough investigation.
Purpose of the Study:
- To evaluate the association between early antenatal exposure to low-dose aspirin and neurodevelopmental outcomes in children.
- To determine if low-dose aspirin is noninferior to placebo in terms of child neurodevelopment.
Main Methods:
- A noninferiority, masked neurodevelopmental follow-up study.
- Involved 640 children aged 33-39 months whose mothers received low-dose aspirin or placebo from early gestation.
- Neurodevelopment assessed using Bayley-III and ASQ-3.
Main Results:
- Bayley-III cognitive composite scores were noninferior between aspirin and placebo groups (adjusted mean difference -0.8).
- No significant differences observed in language or motor composite scores.
- ASQ-3 components and rates of low Bayley-III scores (<70) were similar between groups.
Conclusions:
- Early antenatal exposure to low-dose aspirin is not associated with altered neurodevelopmental outcomes at age 3 years.
- Findings support the safety of low-dose aspirin use in pregnancy regarding child neurodevelopment.
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.
Clinical Trial Registration:
ClinicalTrials.gov , NCT04888377.
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