Assessing Iodine Status and Associated Health Outcomes in British Women During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 主要终点
- Born in Bradford: Early Years Foundation Stage (EYFS) profiles
研究概览
简要总结
Iodine is a key micronutrient in the diet, essential for healthy growth, and is particularly important during pregnancy and breastfeeding when demands are increased to support the developing baby. Many people are thought to lack all the iodine they need, and this is a greater issue during and shortly after pregnancy when the body's iodine requirements are greatest. Iodine deficiency complications are potentially serious for both mother and child. Iodine deficiency can lead to thyroid enlargement, lower production of important hormones produced by the thyroid, pregnancy complications in the mother, and impaired growth and developmental problems in babies and children. This research will focus on providing an up-to-date estimate of how many pregnant women do not have enough iodine, and what different levels of iodine might mean in terms of health risks during pregnancy and for childhood development. The investigators will investigate how iodine levels vary over the course of pregnancy and lactation, how this is affected by diet, associated changes in thyroid size and function, and what levels of iodine are linked with greater risk of subsequent health problems. The research will take advantage of existing urine samples collected from mothers during pregnancy in the Born in Bradford birth cohort study, where the investigators also know of any adverse pregnancy outcomes, as well as any developmental problems for the baby and in early childhood.
详细描述
Background: Pregnant women may be particularly vulnerable to iodine deficiency as requirements increase to support fetal development. There is limited information concerning how maternal iodine status changes during pregnancy. Severe iodine deficiency is associated with deleterious health outcomes during pregnancy including gestational diabetes, preeclampsia, stillbirth, and increased mortality. For the fetus, severe iodine deficiency results in reduced birthweight, increased mortality and neurodevelopmental issues. Several studies suggest 40% of pregnant mothers in the United Kingdom (UK) may not meet the World Health Organization (WHO) definition of iodine sufficiency. Although the effects of severe iodine deficiency are known, the impact of mild-to-moderate deficiencies on maternal health and associated fetal and childhood development are not well understood.
Aims:
- To provide up-to-date information on iodine status in pregnant women in the UK, including changes during pregnancy and lactation, and the role of diet.
- To quantify any associations between iodine status during pregnancy, pregnancy outcomes, and cognitive and motor development of the child.
- To compare the iodine status of mothers in the Born in Bradford cohort to a more nationally representative sample.
Research plan and methods: The investigators will utilize the Born in Bradford (BiB) birth cohort which recruited over 12000 pregnant women between 2007- 2009, and has deposited in a biobank 6971 spot urine samples collected at 26-28 weeks gestation.
Data are available on health outcomes during pregnancy including gestational diabetes, preeclampsia, blood pressure, length of gestation, mortality, mental health. Child outcome measures at birth include weight, length, head circumference, small-for-gestational-age. Childhood developmental measures include height, weight, growth trajectories, motor skills, literacy, numeracy and mental health (Strengths and Difficulties Questionnaire, SDQ). Linkage with educational outcomes has been achieved, including Early Years Foundation Stage (EYFS) outcomes and Standard Assessment Tests (SATS) at both Key Stage 1 (KS1) and Key Stage 2 (KS2).
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Born in Bradford: Early Years Foundation Stage (EYFS) profiles
时间窗: Ages 3 to 5
The EYFS average points total over 17 domains (score range 17 to 41) and summarised using achievement of Good Level of Development (GLD) (binary).
次要结局
- Born in Bradford: Social functioning(Ages 3 to 5)
- Hiba longitudinal cohort: thyroid stimulating hormone (TSH)(12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.)
- Hiba longitudinal cohort: thyroglobulin(12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.)
- Born in Bradford: Letter identification(Ages 3 to 5)
- Hiba longitudinal cohort: free thyroxine (fT4)(12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.)
- Born in Bradford: Receptive vocabulary(Ages 3 to 5)
- Born in Bradford: Fine motor skills(Ages 3 to 5)
- Born in Bradford: Diagnosis of autism(Up to age 11.)
- Born in Bradford: Key Stage 1 (KS1) educational outcomes(Ages 5 to 8)
- Hiba longitudinal cohort: thyroid size(12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.)
- Hiba longitudinal cohort: maternal dietary iodine intake (micrograms)(12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.)
- Born in Bradford: Birth weight centile(At birth)
- Born in Bradford: Apgar score(At 1 minute and 5 minutes after birth.)
- Born in Bradford: Diagnosis of attention deficit hyperactivity disorder (ADHD)(Up to age 11.)
- Hiba longitudinal study: Urinary iodine status(12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.)
- Hiba longitudinal cohort: triiodothyronine (fT3)(12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.)
研究者
Darren Greenwood
Senior Lecturer in Biostatistics
University of Leeds