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Long-term child outcomes after prenatal aspirin exposure: A 4-year follow-up of a randomized controlled trial (the
Emilie V J van Limburg Stirum1,2, Janneke van 't Hooft1,2, Anadeijda J E M C Landman2,3
1Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Insights
Prenatal low-dose aspirin (80 mg daily) showed no harmful long-term child outcomes up to 4 years of age. This study confirms the safety of aspirin use during pregnancy for child development and behavior.
Area of Science:
- Obstetrics and Gynecology
- Pediatric Development
- Clinical Pharmacology
Background:
- Prenatal exposure to medications requires careful evaluation of long-term child outcomes.
- Low-dose aspirin is used in pregnancy for conditions like recurrent spontaneous preterm labor.
- Understanding the safety profile of aspirin on child neurodevelopment is crucial.
Purpose of the Study:
- To assess long-term child outcomes, including neurodevelopment and behavior, following prenatal exposure to low-dose aspirin.
- To evaluate the safety of daily 80 mg aspirin compared to placebo in singleton pregnancies.
- To analyze data on mortality, general health, and growth up to 4 years corrected age.
Main Methods:
- Follow-up of a randomized controlled trial (APRIL study) comparing aspirin (n=194) to placebo (n=193).
- Children assessed at 4 years corrected age using Ages and Stages Questionnaire (ASQ-3) and Strengths and Difficulties Questionnaire (SDQ).
- Data collection included mortality, general health, growth, and a composite outcome of abnormal child development or mortality.
Main Results:
- No significant differences in the rate of children with ASQ-3 scores below normative data (35.2% vs. 47.4%) or SDQ scores in the highest centile (18.3% vs. 14.7%) between aspirin and placebo groups.
- Total ASQ-3 scores were slightly higher in the aspirin group (mean difference 10.96).
- General health, growth, and composite outcomes did not significantly differ between the groups.
Conclusions:
- Daily prenatal exposure to 80 mg aspirin demonstrated no harmful effects on child outcomes at 4 years corrected age.
- Findings support the safety of low-dose aspirin use in pregnancy.
- This study adds to the evidence base confirming the safety of aspirin during pregnancy.
Objective:
To identify the long-term child outcomes after prenatal aspirin exposure.
Methods:
This study is a follow-up of a randomized controlled trial (RCT) evaluating low-dose aspirin in the prevention of recurrent spontaneous preterm labor (the APRIL study) comparing aspirin 80 mg daily (n = 194) to placebo (n = 193) in singletons. Children were assessed at 4 years corrected age using the Ages and Stages Questionnaire (third edition, ASQ-3) and the Strengths and Difficulties Questionnaire (SDQ) for (neuro)development and behavioral outcomes, respectively. Data on mortality, general health, growth and a composite of abnormal child outcome or mortality were also collected. Analyses were performed reporting odds ratio (OR) and 95% confidence intervals (CIs).
Results:
Eight children were deceased until 4 years follow-up (all perinatal deaths; n = 6 in aspirin and n = 2 in the placebo group). We included 231/379 (60.9%) children: 111/231 in the aspirin and 120/231 in the placebo groups. Total ASQ-3 score was higher in the aspirin group (mean 259.3 vs. 248.3, mean difference 10.96, 95% CI: 0.17-21.76). The rate of children with an ASQ-3 score of ≥1SD below the normative data did not differ between groups (35.2% vs. 47.4%; OR 0.60, 95% CI: 0.33-1.09), nor did a score on the SDQ ≥80th centile (18.3% vs. 14.7%; OR 1.30, 95% CI: 0.64-2.66). General health, growth and the composite outcome of abnormal child development or mortality did not significantly differ between groups.
Conclusion:
We found no harmful effects of daily prenatal exposure to aspirin 80 mg. Our findings contribute to the existing data confirming the safety of low-dose aspirin use in pregnancy.
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