Follow-Up of Children Born to Mothers in Folic Acid Clinical Trial (FACT 4 Child): A Prospective Cohort Study Based on a Double-Blinded Randomised Controlled Trial.
Date
2025
Authors
Ghiasi, M.
Zwaigenbaum, L.
Moddemann, D.
White, R.R.
Dingwall-Harvey, A.L.J.
Grattan, K.P.
Murray, M.
Rybak, N.
Walker, H.
Lacaze-Masmonteil, T.
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Journal article
Citation
BJOG: An International Journal of Obstetrics and Gynaecology, 2025; 1-10
Statement of Responsibility
Maryam Ghiasi, Lonnie Zwaigenbaum, Diane Moddemann, Ruth Rennicks White, Alysha L. J. Dingwall-Harvey, Kimberly P. Grattan, Marisa Murray, Natalie Rybak, Heather Walker, Thierry Lacaze-Masmonteil, Elizabeth Asztalos, Laura M. Gaudet, Stephen Robson, William Hague, Donnette Simms-Stewart, Graeme Smith, Emmanuel Bujold, Daniel J. Corsi, Gary Goldfield, Darine El-Chaâr, Shi Wu Wen, Mark C. Walker
Conference Name
Abstract
Objective: To assess the impact of high-dose folic acid supplementation (4.0–5.1 mg), started between 8⁺⁰ and 16⁺⁶ weeks of gestation and continued until delivery, on social impairments associated with Autism Spectrum Disorders, deficiencies in executive function, and emotional and behavioural problems in children. Design: FACT 4 Child is a follow-up of mothers and their children born during the Folic Acid Clinical Trial (FACT), an international multi-centre double-blinded randomised trial to assess the effect of high-dose folic acid supplementation on preventing preeclampsia in women with increased risk. Setting: Multi-centre international follow-up study. Population: Mothers and their children enrolled in FACT, among them 664 completed the follow-up. Methods: Mothers reported on social and executive function and emotional and behavioural problems in their children aged 4–9 years using standardised, validated questionnaires. Main Outcome: The proportion of children with at least one score > 1.5 SD above expected mean. Results: Among 319 children in the intervention group, 43 (13.5%) had a score in the elevated range, compared with 51/345 (14.8%) in the placebo group (RR = 0.91; 95% CI: 0.63 to 1.33; p = 0.63). Conclusion: In children born to women at risk for preeclampsia, rates of neurodevelopmental outcomes were not different between high-dose folic acid and control groups in this study. Our finding suggests that a high dose of folic acid supplementation may not be needed in pregnant women with increased risk. A larger-scale study is needed to determine neurodevelopmental outcomes associated with different dosages and timing of folic acid supplementation during pregnancy.
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First published: 27 August 2025.
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© 2025 John Wiley & Sons