Department of Midwifery, Varamin-Pishva Branch, Islamic Azad University, Tehran, Iran/, Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran.
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, 24 Parvaneh, Yaman Street, Velenjak, P.O.Box: 19395-4763, Tehran, 1985717413, Islamic Republic of Iran.
Arch Gynecol Obstet. 2024 Mar;309(3):975-985. doi: 10.1007/s00404-023-06954-5. Epub 2023 Feb 23.
Despite the beneficial effects of levothyroxine (LT4) therapy on pregnancy outcomes of women with subclinical hypothyroidism (SCH), its impact on the developmental status of offspring remains unclear. We aimed to assess the effects of LT4 therapy on the neurodevelopment of infants of SCH women in the first 3 years of life.
A follow-up study was conducted on children born to SCH pregnant women who had participated in a single-blind randomized clinical trial (Tehran Thyroid and Pregnancy Study). In this follow-up study, 357 children of SCH mothers were randomly assigned to SCH + LT4 (treated with LT4 after the first prenatal visit and throughout pregnancy) and SCH-LT4 groups. Children born of euthyroid TPOAb-women served as the control group (n = 737). The neurodevelopment status of children was assessed in five domains (communication, gross motor, fine motor, problem-solving, and social-personal domains) using the Ages and Stages Questionnaires (ASQ) at the age of 3 years.
Pairwise comparisons of ASQ domains between euthyroid, SCH + LT4, and SCH-LT4 groups show no statistically significant difference between groups in the total score [median 25-75 total score: 265 (240-280); 270 (245-285); and 265 (245-285); P-value = 0.2, respectively]. The reanalyzing data using the TSH cutoff value of 4.0 mIU/L indicated no significant difference between groups in the score of ASQ in each domain or total score with TSH levels < 4.0 mIU/L, however, a statistically significant difference in the median score of the gross motor was observed between those SCH + LT4 with baseline TSH values ≥ 4.0 mIU/L and SCH-LT4 [60 (55-60) vs. 57.5 (50-60); P = 0.01].
Our study does not support the beneficiary effect of LT4 therapy for SCH pregnant women in terms of the neurological development of their offspring in the first three years of life.
尽管左甲状腺素（LT4）治疗对亚临床甲状腺功能减退症（SCH）女性的妊娠结局有益，但它对后代发育状况的影响仍不清楚。我们旨在评估 LT4 治疗对 SCH 女性婴儿在生命的头 3 年神经发育的影响。
对参加单盲随机临床试验（德黑兰甲状腺与妊娠研究）的 SCH 孕妇所生的儿童进行了随访研究。在这项随访研究中，357 名 SCH 母亲的孩子被随机分配到 SCH+LT4（在首次产前检查后并在整个孕期内使用 LT4 治疗）和 SCH-LT4 组。甲状腺过氧化物酶抗体阳性的甲状腺功能正常妇女所生的儿童作为对照组（n=737）。在 3 岁时，使用年龄和阶段问卷（ASQ）评估儿童的神经发育状况，共 5 个领域（沟通、大运动、精细运动、解决问题和社会-个人领域）。
对甲状腺功能正常、SCH+LT4 和 SCH-LT4 组的 ASQ 各领域进行两两比较，发现各组间总评分无统计学差异[中位数 25-75 总评分：265（240-280）；270（245-285）；265（245-285）；P 值=0.2]。使用 TSH 截断值 4.0 mIU/L 重新分析数据，发现 TSH 水平<4.0 mIU/L 时，各组 ASQ 各领域评分或总分无显著差异，但 TSH 基线值≥4.0 mIU/L 的 SCH+LT4 与 SCH-LT4 组之间，大运动的中位数评分存在显著差异[60（55-60）与 57.5（50-60）；P=0.01]。
我们的研究结果不支持 SCH 孕妇 LT4 治疗对其后代头 3 年神经发育有益。
