학술논문
Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy.
Document Type
Academic Journal
Author
Hoffman MK; Christiana 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.; 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
Source
Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0401101 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-233X (Electronic) Linking ISSN: 00297844 NLM ISO Abbreviation: Obstet Gynecol Subsets: MEDLINE
Subject
Language
English
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.
Competing Interests: Financial Disclosure Nancy F. Krebs disclosed a financial relationship with Nurture, Inc, The Danone Company, Pediatric and Maternal Nutrition, and Happy Family Advisory Board. Patricia Hibberd disclosed that money was paid to her institution from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Fogarty International Center, the Foundation for the National Institutes of Health, and the Bill and Melinda Gates Foundation. Michelle A. Lobo disclosed receiving a consulting fee from the Thrasher Foundation, which supported this work. The other authors did not report any potential conflicts of interest.
(Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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.
Competing Interests: Financial Disclosure Nancy F. Krebs disclosed a financial relationship with Nurture, Inc, The Danone Company, Pediatric and Maternal Nutrition, and Happy Family Advisory Board. Patricia Hibberd disclosed that money was paid to her institution from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Fogarty International Center, the Foundation for the National Institutes of Health, and the Bill and Melinda Gates Foundation. Michelle A. Lobo disclosed receiving a consulting fee from the Thrasher Foundation, which supported this work. The other authors did not report any potential conflicts of interest.
(Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)