Evaluation of the impact of levothyroxine treatment on the psychomotor developmental status of three-year-old children born to mothers with mild thyroid impairment; Tehran Thyroid and pregnancy study: study protocol for a randomized clinical trial

Abstract

BackgroundDespite 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/DesignThis 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).DiscussionThe 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 registrationIranian Registry of Clinical Trials, IRCT2017090314849N5. Registered on 11 September 2017. Iranian Registry of Clinical Trials, IRCT2017090414849N6. Registered on 14 October 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3130-5) contains supplementary material, which is available to authorized users.

Levothyroxine in Pregnancy

“…Treatment of hypothyroid mothers in the second trimester did not improve neurocognitive outcomes in the offspring [46]. A follow-up study to the Tehran Thyroid and Pregnancy Study will evaluate the neurocognitive development of 3-year old children born to mothers with mild hypothyroidism (without TAI) [47].…”