Registry Study on Effect of Excessive Iodine Exposure on Maternal and Fetal Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 195
- 主要终点
- comprehensive offspring outcomes in long term - weight evaluation
研究概览
简要总结
Pre-gestational performance of hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium has been demonstrated to be the main cause of excessive iodine exposure for pregnant women. However, its long-term health effects on the mothers and offsprings have not been adequately elucidated. A case registry study is designed to follow up all the pregnant women with pre-gestational history of ethiodized-oil HSG examination and try to keep track of maternal and fetal outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be pregnant when enrolled in this study. Must have undergone examination of ethiodized-oil HSG before this pregnancy. Clinical diagnosis of iodine excess (with the mean urine iodine concentration ≥250μg/L and the serum iodine concentration >92μg/L).
排除标准
- •Having past history of partial or total resection of thyroid glands. Having medical history of thyroid dysfunction before ethiodized-oil HSG examination.
结局指标
主要结局
comprehensive offspring outcomes in long term - weight evaluation
时间窗: from birth to age of 1 year old, assessed every 3-6 months
weight of offsprings
comprehensive pregnant outcomes_prevalence of gestational diabetes
时间窗: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
prevalence of gestational diabetes
comprehensive neonatal outcomes at delivery
时间窗: at the time of delivery
Apgar scores of neonates
offspring outcomes_neurodevelopment evaluation in long term
时间窗: from birth to age of 1 year old, assessed every 6 months
Norwegian version of the Ages and Stages Questionnaire (ASQ) scores for evaluation of infant neurodevelopment
comprehensive offspring outcomes in long term - BMI evaluation
时间窗: from birth to age of 1 year old, assessed every 3-6 months
BMI of offsprings
comprehensive pregnant outcomes_prevalence of gestational hypertension
时间窗: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
prevalence of gestational hypertension
comprehensive pregnant outcomes_rate of cesarean section
时间窗: at the time of delivery
rate of cesarean section
comprehensive pregnant outcomes_prevalence of abnormal pregnancy
时间窗: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
prevalence of abnormal pregnancy (stillbirth, abortion, premature delivery)
comprehensive neonatal outcomes_neonatal head circumference
时间窗: at the time of delivery
head circumference of neonates
comprehensive neonatal outcomes_prevalence of macrosomia or underweight
时间窗: at the time of delivery
prevalence of macrosomia or underweight
comprehensive neonatal outcomes_neonatal weight
时间窗: at the time of delivery
birth weight of neonates
comprehensive neonatal outcomes_neonatal height
时间窗: at the time of delivery
height of neonates
comprehensive neonatal outcomes_neonatal BMI
时间窗: at the time of delivery
BMI of neonates
offspring outcomes_prevalence of thyroid dysfunction
时间窗: from birth to age of 1 year old, assessed every 6 months
prevalence of thyroid dysfunction (hyperthyroidism or hypothyroidism)
comprehensive offspring outcomes in long term - height evaluation
时间窗: from birth to age of 1 year old, assessed every 3-6 months
height of offsprings
次要结局
- prevalence of thyroid dysfunction in pregnancy(during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months)
- prevalence of iodine overload in neonates(within 1 week after birth of neonates)
研究者
Rongrong Li
nutrition physician
Peking Union Medical College Hospital