Iodine Overload in Pregnancy Clinical Trial
Official title:
Registry Study on Effect of Excessive Iodine Exposure on Maternal and Fetal Outcomes
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.
| Status | Not yet recruiting |
| Enrollment | 195 |
| Est. completion date | June 1, 2020 |
| Est. primary completion date | March 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: 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). Exclusion Criteria: Having past history of partial or total resection of thyroid glands. Having medical history of thyroid dysfunction before ethiodized-oil HSG examination. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Peking Union Medical College Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | comprehensive pregnant outcomes_prevalence of gestational diabetes | prevalence of gestational diabetes | during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months | |
| Primary | comprehensive pregnant outcomes_prevalence of gestational hypertension | prevalence of gestational hypertension | during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months | |
| Primary | comprehensive pregnant outcomes_prevalence of abnormal pregnancy | prevalence of abnormal pregnancy (stillbirth, abortion, premature delivery) | during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months | |
| Primary | comprehensive pregnant outcomes_rate of cesarean section | rate of cesarean section | at the time of delivery | |
| Primary | comprehensive neonatal outcomes at delivery | Apgar scores of neonates | at the time of delivery | |
| Primary | comprehensive neonatal outcomes_neonatal weight | birth weight of neonates | at the time of delivery | |
| Primary | comprehensive neonatal outcomes_neonatal head circumference | head circumference of neonates | at the time of delivery | |
| Primary | comprehensive neonatal outcomes_neonatal height | height of neonates | at the time of delivery | |
| Primary | comprehensive neonatal outcomes_neonatal BMI | BMI of neonates | at the time of delivery | |
| Primary | comprehensive neonatal outcomes_prevalence of macrosomia or underweight | prevalence of macrosomia or underweight | at the time of delivery | |
| Primary | offspring outcomes_prevalence of thyroid dysfunction | prevalence of thyroid dysfunction (hyperthyroidism or hypothyroidism) | from birth to age of 1 year old, assessed every 6 months | |
| Primary | offspring outcomes_neurodevelopment evaluation in long term | Norwegian version of the Ages and Stages Questionnaire (ASQ) scores for evaluation of infant neurodevelopment | from birth to age of 1 year old, assessed every 6 months | |
| Primary | comprehensive offspring outcomes in long term - weight evaluation | weight of offsprings | from birth to age of 1 year old, assessed every 3-6 months | |
| Primary | comprehensive offspring outcomes in long term - height evaluation | height of offsprings | from birth to age of 1 year old, assessed every 3-6 months | |
| Primary | comprehensive offspring outcomes in long term - BMI evaluation | BMI of offsprings | from birth to age of 1 year old, assessed every 3-6 months | |
| Secondary | prevalence of thyroid dysfunction in pregnancy | evaluation of maternal TSH, T3, T4, FT3, FT4, TRAb,Tg-Ab, TPO-Ab | during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months | |
| Secondary | prevalence of iodine overload in neonates | prevalence of infants with urinary iodine concentration =200µg/L | within 1 week after birth of neonates |