NCT00379535终止3 期
Phase III : Preventing Lack of Iodine During Pregnancy. Effect of Supplying Woman With Potassium Iodine to the Neuro-Cognitive Children Development Until Two Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on neuro-cognitive development of children followed up until two years.
详细描述
374 patients with pregnancy less 12 weeks amenorrhea
Patients randomized in 2 parallel groups (each group with 187 patients)
- one group with 200 µg of potassium iodide
- one group with placebo
Follow up during 3 years with :
- a selection visit, an inclusion with randomization before 12 weeks amenorrhea
- and follow up visit at the 5th month and 8th month of pregnancy, the day of birth, and 6, 12, and 24 months " post partum "
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with pregnancy less 12 weeks amenorrhea , with clinically normal pregnancy, unique or twiny
- •Patients who agree to take part in the study and able to sign an Informed Consent Form
排除标准
- •Patients receiving a treatment for thyroid affection, or with thyroid pathology
- •Patients with a chronic pathology like insulin dependent diabetes or arterial hypertension
- •Patients with a treatment supplying iodine or having had a gynecologic exam with a iodine solution in the last 30 days
- •Patients taking part in another clinical test or in the last 30 days
- •Patients with depressive antecedent before pregnancy or taking antidepressant treatment
- •Psychiatric troubles that may interfere with the clinical evaluation
- •Patients under special supervision or trusteeship
- •No social security cover
研究组 & 干预措施
1
Experimental
Daily dose of 200 µg of potassium iodide
干预措施: potassium iodide (Drug)
2
Placebo Comparator
Daily dose of placebo
干预措施: placebo (Drug)
结局指标
主要结局
Supplying a daily dose of 200 µg of potassium iodide in comparison with a placebo dose to pregnant woman and evaluate the impact on neuro-cognitive development of children followed up until two years
时间窗: 2 years
次要结局
- Prevalence of hypothyroxinemia and hypothyroidism during pregnancy(9 months max)
- Change in the functional thyroid parameters of mother during iodine treatment(2 years)
- Comparison of the psychometric development of children , for woman with and without treatment(6, 12, and 24 months)
- Quantify the iodine supply from the woman to the baby during the breast feeding for woman with and without iodine treatment(3 months)
研究者
研究点 (1)
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