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Research on Excessive Iodine Status in Pregnancy

A Prospective Observational Study on Health Effect of Excessive Iodine Exposure in Pregnancy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03422406
Enrollment
18
Registered
2018-02-05
Start date
2016-01-31
Completion date
2017-03-31
Last updated
2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive Iodine Status, Neonatal Disorder, Pregnancy Related, Thyroid Dysfunction, Antepartum

Keywords

Iodine excess, Cause, Pregnancy, Urinary iodine concentration, Serum iodine concentration, Breast milk iodine concentration

Brief summary

To explore main cause and health impact of iodine excess during pregnancy, we performed iodine evaluation for 390 consecutive pregnant women from January 1st, 2016 to December 31st, 2016. Among them, 18 women (4.62%) with apparently elevated urinary iodine concentration (UIC) were enrolled onto this study for subsequent follow-up. History of high iodine exposure was collected from all participants. Parameters about iodine status were monitors until termination of pregnancy, and dietary iodine intake condition and thyroid function were also evaluated.

Detailed description

A prospective follow-up was arranged for the 18 pregnant women with excessive iodine status. History of iodine exposure (including hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium, examination by computed tomography scan with contrast, administration of amiodarone, history of receiving radioiodine therapy, etc.) was collected from all participants. Evaluation of dietary iodine intake was performed through a 72-hour dietary recall.The serum iodine concentration (SIC) and urinary iodine concentration (UIC) were monitored continuously in the whole course of pregnancy. All subjects with excessive iodine load were recommended by nutritionists to have their dietary iodine intake restricted, and resume iodine-containing supplements and foods until the UIC\<250 μg/L and SIC≤90 μg/L. After delivery, maternal colostrum iodine concentration and neonatal iodine status (including neonatal UIC, condition of congenital hypothyroidism screening tests, and thyroid physical examination) were also assessed.

Interventions

OTHERDietary iodine intake restriction

All subjects with excessive iodine load were recommended by nutritionists to restrict dietary iodine intake, and resume iodine-containing supplements and foods until their iodine status return to normal. However, in this observational study, the intervention was a regular management in prenatal care, and not assigned by investigator of the study.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Pregnant women with apparently elevated urinary iodine concentration (UIC ≥250μg/L) and serum iodine concentration (SIC\>90μg/L) were enrolled in this study.

Exclusion criteria

* Subject who did not sign the informed consent or whose clinical date was not intact was excluded in our study.

Design outcomes

Primary

MeasureTime frameDescription
prevalence of adverse pregnancy outcome6-9 months post identification of maternal iodine excessprevalence of stillbirth, abortion and other adverse pregnancy outcome
composite neonatal outcome6-9 months post identification of maternal iodine excessApgar scores, birth weight of the neonates,and prevalence of thyroid dysfunction in neonates

Secondary

MeasureTime frameDescription
prevalence of maternal thyroid dysfunction in pregnancythrough study completion, about 6-9 months post identification of maternal iodine excessLaboratory reference ranges of TSH during pregnancy were 0.1\ 2.5 mIU/L for the first trimester, 0.2\ 3.0 mIU/L for the second trimester and 0.3\ 3.0 mIU/L for the third trimester.Prevalence of TSH elevation during pregnancy will be summarized.
prevalence of neonatal iodine excesswithin 1 week after birthurinary iodine concentration will be examined for all neonates born to women with iodine excess in pregnancy, and prevalence of neonatal urinary iodine concentration ≥ 200μg/L will be summarized.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026