Iodine Overload in Pregnancy
Conditions
Brief summary
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.
Interventions
OTHERdietary iodine restriction on subjects with iodine overload
In this case registry study (observational study),all intervention will be performed not for research purposes, but only part of routine treatment, which will be recorded in database of the registry study.
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comprehensive offspring outcomes in long term - BMI evaluation | from birth to age of 1 year old, assessed every 3-6 months | BMI of offsprings |
| comprehensive offspring outcomes in long term - weight evaluation | from birth to age of 1 year old, assessed every 3-6 months | weight of offsprings |
| comprehensive offspring outcomes in long term - height evaluation | from birth to age of 1 year old, assessed every 3-6 months | height of offsprings |
| comprehensive pregnant outcomes_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 | prevalence of gestational diabetes |
| comprehensive pregnant outcomes_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 | prevalence of gestational hypertension |
| comprehensive pregnant outcomes_prevalence of abnormal 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 abnormal pregnancy (stillbirth, abortion, premature delivery) |
| comprehensive pregnant outcomes_rate of cesarean section | at the time of delivery | rate of cesarean section |
| comprehensive neonatal outcomes at delivery | at the time of delivery | Apgar scores of neonates |
| comprehensive neonatal outcomes_neonatal weight | at the time of delivery | birth weight of neonates |
| comprehensive neonatal outcomes_neonatal head circumference | at the time of delivery | head circumference of neonates |
| comprehensive neonatal outcomes_neonatal height | at the time of delivery | height of neonates |
| comprehensive neonatal outcomes_neonatal BMI | at the time of delivery | BMI of neonates |
| comprehensive neonatal outcomes_prevalence of macrosomia or underweight | at the time of delivery | prevalence of macrosomia or underweight |
| offspring outcomes_prevalence of thyroid dysfunction | from birth to age of 1 year old, assessed every 6 months | prevalence of thyroid dysfunction (hyperthyroidism or hypothyroidism) |
| offspring outcomes_neurodevelopment evaluation in long term | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of iodine overload in neonates | within 1 week after birth of neonates | prevalence of infants with urinary iodine concentration ≥200μg/L |
| 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 | evaluation of maternal TSH, T3, T4, FT3, FT4, TRAb,Tg-Ab, TPO-Ab |
Contacts
Primary ContactRongrong Li
Outcome results
None listed