Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Hoffman MK

PROVIDER: S-EPMC10953679 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

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

Hoffman Matthew K MK Goudar Shivaprasad S Dhaded Sangappa S Figueroa Lester L Mazariegos Manolo M Krebs Nancy F NF Westcott Jamie J Tikmani Shiyam Sunder SS Karim Fatima F Saleem Sarah S Goldenberg Robert L RL Lokangaka Adrien A Tshefu Antoinette A Bauserman Melissa M Patel Archana A Das Prabir P Hibberd Patricia P Chomba Elwyn E Mwenchanya Musaku M Carlo Waldemar A WA Trotta Marissa M Williams Alexis A Moore Janet J Nolen Tracy T Goco Norman N McClure Elizabeth M EM Lobo Michele A MA Cunha Andrea B AB Derman Richard J RJ

Obstetrics and gynecology 20240123 4

<h4>Objective</h4>Because low-dose aspirin is now commonly prescribed in pregnancy, we sought to assess the association between early antenatal exposure and child neurodevelopment.<h4>Methods</h4>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-II ...[more]

PMID: 38262066

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Project description:BackgroundThere are limited data on long-term outcomes of children whose mothers have followed exercise interventions during pregnancy. The aim of this paper was to investigate whether regular moderate intensity exercise during pregnancy affected the children's body mass index (BMI) and physical activity (PA) at 7 years of age, and determine the relationship between children's and mothers' BMI and PA.MethodsThis was a follow-up of a multicentre randomised controlled trial, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007-2009 and 2014-2016). Women were randomised to follow a 12-week structured exercise protocol or standard antenatal care during pregnancy. At the 7-year follow-up, parents reported their child's height, weight, and PA. The mothers also reported their own weight and PA. Main outcome variables were BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA.ResultsA total of 855 women were randomised to exercise (n = 429) or standard antenatal care (n = 426) during pregnancy. At follow-up, 164 (38.2%) children and mothers in the intervention group and 117 (27.5%) in the control group participated. We found no group differences in the children's iso-BMI or PA. Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group. Subgroup analyses of children of mothers who adhered to the exercise protocol and sensitivity analyses excluding children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up, did not change the results. Children's BMI, weekly leisure time MVPA and intensity of PA correlated with mothers' BMI, daily exercise, and intensity of exercise.ConclusionsRegular moderate intensity exercise during pregnancy did not affect BMI or PA of the children at 7 years. Good maternal health should be encouraged as it may influence the health of the next generation.Trial registrationThe initial RCT study was registered in ClinicalTrials.gov NCT00476567 .

Dataset Information

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

Objective

Methods

Results

Conclusion

Clinical trial registration

Publications

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

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