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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

Lookup NU author(s): Professor Steve RobsonORCiD

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Abstract

© 2025 John Wiley & Sons Ltd.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.

Publication metadata

Author(s): Ghiasi M, Zwaigenbaum L, Moddemann D, White RR, Dingwall-Harvey ALJ, Grattan KP, Murray M, Rybak N, Walker H, Lacaze-Masmonteil T, Asztalos E, Gaudet LM, Robson S, Hague W, Simms-Stewart D, Smith G, Bujold E, Corsi DJ, Goldfield G, El-Chaar D, Wen SW, Walker MC

Publication type: Article

Publication status: Published

Journal: BJOG: An International Journal of Obstetrics and Gynaecology

Year: 2025

Pages: epub ahead of print

Online publication date: 27/08/2025

Acceptance date: 11/08/2025

ISSN (print): 1470-0328

ISSN (electronic): 1471-0528

Publisher: John Wiley and Sons Inc

URL: https://doi.org/10.1111/1471-0528.18341

DOI: 10.1111/1471-0528.18341

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