Registry Study for Pregnant Women With Iodine Overload
- Conditions
- Iodine Overload in Pregnancy
- Interventions
- Other: dietary iodine restriction on subjects with iodine overload
- Registration Number
- NCT03470597
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 195
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).
Having past history of partial or total resection of thyroid glands. Having medical history of thyroid dysfunction before ethiodized-oil HSG examination.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant women with pre-gestational HSG history dietary iodine restriction on subjects with iodine overload All enrolled pregnant women with pre-gestational ethiodized-oil HSG will be followed up without grouping and be kept track for maternal and offspring's health outcomes in this case registry study.
- Primary Outcome Measures
Name Time Method 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 neonatal outcomes at delivery at the time of delivery Apgar scores of neonates
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
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 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_rate of cesarean section at the time of delivery rate of cesarean section
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 neonatal outcomes_neonatal head circumference at the time of delivery head circumference of neonates
comprehensive neonatal outcomes_prevalence of macrosomia or underweight at the time of delivery prevalence of macrosomia or underweight
comprehensive neonatal outcomes_neonatal weight at the time of delivery birth weight 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
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)
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
- Secondary Outcome Measures
Name Time Method 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
prevalence of iodine overload in neonates within 1 week after birth of neonates prevalence of infants with urinary iodine concentration ≥200μg/L