Observational Study on the Impact of Iodine Supplementation on Maternal and Child's Thyroid Hormone Homeostasis and on the Child's Psychomotor Development, in the Portuguese Minho Region (IodineMinho)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 304
- 试验地点
- 10
- 主要终点
- Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region
研究概览
简要总结
Full intellectual capabilities are achieved only if crucial nutrients are present during development. Iodine deficiency is the most common cause of preventable brain harm in infants. Because of its critical need during pregnancy, several countries implemented programs of iodine supplementation in preconception and pregnancy. In 2013, the prevalence of iodine deficiency in Portugal has led health authorities to issue a recommendation for iodine supplementation. This study aims to evaluate the impact of iodine supplementation on maternal and fetal iodine status and thyroid function, obstetric outcomes, quality of breast milk and child psychomotor development. It also intends to evaluate whether the time of iodine supplementation initiation influences all the above-mentioned parameters. The novelty and relevance of this study reside on the number of women/child and on the extent of health parameters that will be evaluated. The information collected will contribute to the detailed characterization of thyroid hormone homeostasis throughout pregnancy and its relationship with iodine supplementation (including time of initiation). The data will provide evidence on whether this iodine supplementation strategy impacted on iodine sufficiency of the mother and the newborns, or if it needs re-evaluation.
详细描述
Iodine is essential for intellectual development. Its deficiency, alone, is the most frequent cause of preventable brain harm in infants. Iodine is required to synthesize thyroid hormones, key components of central nervous system development. Because of its relevance in pregnancy, several countries have implemented iodine supplementation programs in preconception, pregnancy and lactation.
Iodine deficiency has been previously shown in women of childbearing age in Portugal. Because of this, since 2013 the National Health Authorities have recommended supplementing iodine (200 ug/day) in preconception, pregnant and lactating women. However, the latest Cochrane review on the subject does not allow to conclude on whether iodine supplementation strategies implemented to date are efficient. Therefore, this study is of great public health interest.
The objectives are to:
- Evaluate whether the new policy of recommending iodine supplementation in preconception, throughout pregnancy and during lactation impacted on the prevalence of iodine deficiency in the Minho region of Portugal when compared to the same population before the recommendation.
- Evaluate whether the time of initiation of iodine supplementation (if any) influences the serum levels of thyroid hormones in the three trimesters of pregnancy.
- Evaluate whether the serum levels of thyroid hormones in the first trimester of pregnancy predict psychomotor development of the newborn at 12 months of age.
To achieve these aims the investigators will follow: i) 304 women longitudinally, before, during the three trimesters of pregnancy (primary care Health Centres), at delivery and three months after delivery, ii) their children at birth, 3 and 12 months of age; ii) perform a detailed evaluation of parameters of thyroid function (mother and child) and of psychomotor development of the newborns.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of who intend to become pregnant or are pregnant, able to read, write and provide informed consent
排除标准
- •Women transferred from outside the study health centres during pregnancy and women taking iodine supplementation before recruitment.
- •Women not intending to deliver at Hospital de Braga.
结局指标
主要结局
Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region
时间窗: At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant.
Urinary iodine.
Impact of iodine supplementation on maternal serum parameters of thyroid function and urinary iodine in the first trimester of pregnancy
时间窗: First trimester of pregnancy
Serum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-thyroperoxidase), urinary iodine.
Bayley scale assessed psychomotor development at one year of age
时间窗: One year of age
Bayley psychomotor development scale
次要结局
- Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancy(Serum thyroid hormones and urinary iodine before iodine supplementation (if any), 1st, 2nd, 3rd trimesters of pregnancy, after delivery. Thyroid ultrasound at baseline, 3rd trimester and 3 months after delivery.)
- Fetal heart rate and thyroid volume at age 3 months(Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.)
- Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization of newborns(One to 3 days of age (if full term babies), 1 to 3 days and 4th week of age (in premature and low birth weight babies).)
- Iodine and energy composition of human milk 3 months after delivery(Three months after delivery)
研究者
Joana Almeida Palha
Professor
University of Minho