Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Iodine deficiency
研究概览
简要总结
The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women
详细描述
BACKGROUND: It is a priority to achieve an adequate nutritional status of iodine during pregnancy since iodine deficiency in this population may have repercussions on the mother during both gestation and post partum as well as on the foetus, the neonate and the child at different ages. According to the WHO, iodine deficiency is the most frequent cause of mental retardation and irrreversible cerebral lesions around the world. However, few studies have been published on the nutritional status of iodine in the pregnant population within the Primary Care setting, a health care level which plays an essential role in the education and control of pregnant women.
AIMS: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the factors associated with its appearance during pregnancy.
METHODS/DESIGN: We will perform a cluster randomised, controlled, multicentre trial. Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of 17 years attending consultation to a midwife during the first trimester of pregnancy in the participating primary care centres. Outcome measures: consumption of iodine-rich foods and iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group education during the first trimester of gestation on healthy hygiene-dietetic habits and the importance of an adequate iodine nutritional status. Statistical analysis: descriptive analysis of all variables will be performed as well as multilevel logistic regression. All analyses will be done carried out on an intention to treat basis and will be fitted for potential confounding factors and variables of clinical importance.
DISCUSSION: Evidence of generalised iodine deficiency during pregnancy could lead to the promotion of interventions of prevention such as how to improve and intensify health care educational programmes for pregnant women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant Women in the first trimester
- •Over the age of 17
- •Receive routine care in their respective health center
排除标准
- •Pregnant women who are in the second or third trimester.
- •Pregnant women with diagnostic of thyroid disease.
- •Pregnant women who do not have a phone.
- •Pregnant women with communication difficulties (cognitive or sensory deterioration, language barrier).
- •Pregnant women who do not consent to participate in the study.
研究组 & 干预措施
Group Education
Group educational workshops about dietary habits in the first trimester because it is when organogenesis occurs and therefore when the iodine deficiency in the mother is an important risk in the development of the fetal central nervous system.
干预措施: Group Education (Other)
Usual care
Women in the control group receive the usual care during the pregnancy
结局指标
主要结局
Iodine deficiency
时间窗: 24 weeks of pregnancy
Urinari iodine excretion below 150 µg/l
次要结局
- Date of birth(At baseline)
- Trimester of pregnancy(Third trimester of pregnancy)
- Glasses of milk a day (number)(Third trimester of pregnancy)
- Smoking(Third trimester of pregnancy (wk28-wk40))
- Education Level(At baseline)
- Iodized salt consumption(Third trimester of pregnancy)
- Number of premature births(At baseline)
- Number of live births(At baseline)
- Yogurt per week (number)(Third trimester of pregnancy)
- Servings of cheese per week (number)(Third trimester of pregnancy)
- Usual preparation of vegetables(Third trimester of pregnancy)
- Use of water to boil vegetables(Third trimester of pregnancy)
- Vegetable consumption per week (number)(Third trimester of pregnancy)
- Iodine supplementation consumption(Third trimester of pregnancy)
- Ethnicity(At baseline)
- Number of pregnancies finishes(At baseline)
- Number of abortions(At baseline)
- Fish consumption per week (number)(Third trimester of pregnancy)
- Usual preparation of fish(Third trimester of pregnancy)
- Canned tuna consumption per week (number)(Third trimester of pregnancy)
- Canned sardines consumption per week (number)(Third trimester of pregnancy)
- Fruit consumption per week (number)(Third trimester of pregnancy)
- Meat consumption per week (number)(Third trimester of pregnancy)
- Cold meat consumption per week (number)(Third trimester of pregnancy)
- Eggs consumption per week (number)(Third trimester or pregnancy)
- Nuts consumption per week (number)(Third trimester of pregnancy)
- Potassium iodide consumption(Third trimester of pregnancy)
- Iodine deficiency(Baseline at first trimester of pregnancy)
研究者
USR Metropolitana Nord
Tecnic de Recerca
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina