Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- 1st trimester urinary iodine concentration
研究概览
简要总结
Data from 2007 regarding iodine status among Portuguese pregnant women indicate this is an iodine deficient population group, with only 16.8% presenting adequate urinary iodine values. This may have serious implications for normal cognitive development of the offspring and a concerning socioeconomic impact. In 2013, concerns by the Portuguese Directorate-General of Health lead to the implementation of a public health policy (nº 011/2013) recommending iodine supplementation during pregnancy. IoMum emerges from this context to monitor and update iodine status in Portuguese pregnant women and to evaluate the effectiveness of the above policy by assessing clinical compliance to iodine supplementation and the impact of iodine supplementation in this vulnerable group. IoMum will update data on iodine nutrition in Portuguese pregnant women, promoting political actions towards the elimination of iodine deficiency and thus to the reduction of nutritional, social and economic inequalities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women attending the 1st trimester fetal ultrasound scan, from the 10th to the 13th gestational week.
排除标准
- •Use of Levothyroxine.
结局指标
主要结局
1st trimester urinary iodine concentration
时间窗: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Median urinary iodine concentration at 1st trimester of gestation
Rate of compliance to iodine supplementation guideline
时间窗: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Rate of compliance to iodine supplementation guideline at 1st trimester of gestation
次要结局
- Maternal median thyroglobulin(Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2))
- 3rd trimester mean sodium excretion(Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2))
- Proportion of pregnant women with insufficient, adequate or excessive iodine intake(Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1))
- 1st trimester mean sodium excretion(Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1))
- Change in median iodine-to-creatinine ratio(Up to 31 weeks)