Authors
Affiliations
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, Iran.
- 1Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
- 2Tehran University of Medical Sciences, Tehran, Iran.
- 3Department of Biostatistics and Epidemiology, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
- 4Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
- 5Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran. fzhadaegh@endocrine.ac.ir.
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Pediatric Neurorehabilitation Research Center, University of Social Welfare & Rehabilitation Sciences, Tehran, Iran.
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Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
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Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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Abstract
Background: Despite the known adverse effects of maternal overt hypothyroidism on the neurocognitive development of children, there is uncertainty regarding the impact of gestational thyroid dysfunction or autoimmune thyroiditis on infant/child neurological development. This study aims to evaluate the impact of levothyroxine (LT4) treatment on the psychomotor developmental status of three-year-old children born to mothers with mild thyroid impairment (subclinical hypothyroidismwith/without autoimmune thyroiditis).
Methods/design: This is a follow-up study of the Tehran Thyroid and Pregnancy Study, a randomized trial in which subclinical hypothyroid pregnant women were assigned to an intervention group (treated with levothyroxine) or a control group (received no treatment). The primary outcome for the purpose of the present study is the developmental status of the children, aged three years, in five domains (communication, gross motor, fine motor, problem-solving, and social-personal domains) using the Ages and Stages Questionnaire (ASQ).
Discussion: The study is designed to assess the developmental status of children born to mothers with mild thyroid impairment (subclinical hypothyroidism with/without autoimmune thyroiditis). This study is one of the limited studies available in this field and has the potential to facilitate much-needed information for related public health policies.
Trial registration: Iranian Registry of Clinical Trials, IRCT2017090314849N5 . Registered on 11 September 2017. Iranian Registry of Clinical Trials, IRCT2017090414849N6 . Registered on 14 October 2017.