Giving Children the Best Start in Life: the Mothers and Babies at Yorkhill Thyroid Health
试验速览
- 阶段
- 不适用
- 入组人数
- 697
- 试验地点
- 1
- 主要终点
- thyroid function of mothers (measurement of TSH and Tg)
研究概览
简要总结
This is an observational study in pregnant mothers and their newborn babies. The rationale of the study is to examine early markers of the effects of iodine insufficiency during pregnancy on thyroid stimulating hormone (TSH) and thyroglobulin in mother and baby.
详细描述
Iodine is a critical component of thyroid hormones, which are essential for normal growth, and brain development, most of the latter occurring during fetal life and in the first three years of life. Maternal dietary iodine is the sole source for fetuses and for exclusively breastfed infants. Recent evidence indicates that the UK female population is not iodine sufficient. Thus a significant proportion of UK pregnant women will also be insufficient in dietary iodine with potential harmful consequences for their babies. We wish to investigate the relationship between maternal iodine status (sufficient versus insufficient) in pregnancy, the mode of neonatal feeding (exclusively breast fed vs exclusively formula fed); and the effect this has on the functioning of the newborn baby's thyroid gland, with provision for later cognitive followup assessment. In order to do this, we will determine:
i) the iodine status of the mother during pregnancy and in the immediate postnatal period (dietary and urinary) and the newborn infant (urinary), ii) the thyroid function of the mother (thyroid stimulating hormone, thyroglobulin, T4 in serum during pregnancy, and thyroid stimulating hormone and thyroglobulin in dried blood spots postpartum) and infant (thyroid stimulating hormone in dried blood spots collected during a routine procedure).
Our hypothesis is that babies whose mothers are iodine insufficient will show higher levels of TSH and thyroglobulin than the babies of iodine sufficient mothers.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women
- •Able to read, write and speak in English
- •Attending a Greater Glasgow and Clyde maternity unit
排除标准
- •Abnormal pregnancies.
- •Mothers with known thyroid disorders.
- •Preterm infants (born before 37 completed weeks).
- •Multiple births.
- •Infants with postnatal problems such as infection or malformation.
结局指标
主要结局
thyroid function of mothers (measurement of TSH and Tg)
时间窗: up to 38 week gestation
measurement of TSH and Tg
thyroid function of infant (routine TSH measurement)
时间窗: Day 4 of life
routine TSH measurement
次要结局
- Iodine status of mothers (iodine intake and excretion)(up to 38 week gestation)
- Iodine level in hair and breastmilk(after birth)
- Iodine status of infant (iodine intake and excretion)(Day 4 of life)
研究者
Emilie Combet
Lecturer
University of Glasgow
