Registry Study for Pregnant Women With Iodine Overload

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.

Study Overview

• Status: Unknown
• Conditions: Iodine Overload in Pregnancy
• Intervention / Treatment: Other: dietary iodine restriction on subjects with iodine overload

• Study Type: Observational
• Enrollment (Anticipated): 195

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with excessive iodine exposure caused by pre-gestational ethiodized-oil HSG

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women with pre-gestational HSG history; 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.	Other: dietary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
comprehensive pregnant outcomes_rate of cesarean section	rate of cesarean section	at the time of delivery
comprehensive neonatal outcomes at delivery	Apgar scores of neonates	at the time of delivery
comprehensive neonatal outcomes_neonatal weight	birth weight of neonates	at the time of delivery
comprehensive neonatal outcomes_neonatal head circumference	head circumference of neonates	at the time of delivery
comprehensive neonatal outcomes_neonatal height	height of neonates	at the time of delivery
comprehensive neonatal outcomes_neonatal BMI	BMI of neonates	at the time of delivery
comprehensive neonatal outcomes_prevalence of macrosomia or underweight	prevalence of macrosomia or underweight	at the time of delivery
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
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
comprehensive offspring outcomes in long term - weight evaluation	weight of offsprings	from birth to age of 1 year old, assessed every 3-6 months
comprehensive offspring outcomes in long term - height evaluation	height of offsprings	from birth to age of 1 year old, assessed every 3-6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
prevalence of iodine overload in neonates	prevalence of infants with urinary iodine concentration ≥200μg/L	within 1 week after birth of neonates

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: March 18, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 18, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Iodine
• Other Study ID Numbers: Liuyanping2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No