Clinical trial NCT03470597: Registry Study for Pregnant Women With Iodine Overload
Official title: Registry Study on Effect of Excessive Iodine Exposure on Maternal and Fetal Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iodine Overload in Pregnancy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with excessive iodine exposure caused by pre-gestational ethiodized-oil HSG

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.


Eligibility criteria: 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.

Primary outcomes:
measure: comprehensive pregnant outcomes_prevalence of gestational diabetes
timeFrame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
measure: comprehensive pregnant outcomes_prevalence of gestational hypertension
timeFrame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
measure: comprehensive pregnant outcomes_prevalence of abnormal pregnancy
timeFrame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
measure: comprehensive pregnant outcomes_rate of cesarean section
timeFrame: at the time of delivery
measure: comprehensive neonatal outcomes at delivery
timeFrame: at the time of delivery
measure: comprehensive neonatal outcomes_neonatal weight
timeFrame: at the time of delivery
measure: comprehensive neonatal outcomes_neonatal head circumference
timeFrame: at the time of delivery
measure: comprehensive neonatal outcomes_neonatal height
timeFrame: at the time of delivery
measure: comprehensive neonatal outcomes_neonatal BMI
timeFrame: at the time of delivery
measure: comprehensive neonatal outcomes_prevalence of macrosomia or underweight
timeFrame: at the time of delivery
measure: offspring outcomes_prevalence of thyroid dysfunction
timeFrame: from birth to age of 1 year old, assessed every 6 months
measure: offspring outcomes_neurodevelopment evaluation in long term
timeFrame: from birth to age of 1 year old, assessed every 6 months
measure: comprehensive offspring outcomes in long term - weight evaluation
timeFrame: from birth to age of 1 year old, assessed every 3-6 months
measure: comprehensive offspring outcomes in long term - height evaluation
timeFrame: from birth to age of 1 year old, assessed every 3-6 months
measure: comprehensive offspring outcomes in long term - BMI evaluation
timeFrame: from birth to age of 1 year old, assessed every 3-6 months
Secondary outcomes:
measure: prevalence of thyroid dysfunction in pregnancy
timeFrame: during the whole pregnancy, from date of verification of pregnancy until the date of termination of pregnancy, assessed up to 10 months
measure: prevalence of iodine overload in neonates
timeFrame: within 1 week after birth of neonates
Other outcomes:
Locations:
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