Research on Excessive Iodine Status in Pregnancy

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422406
• Other study ID #: Liuyanping
• Status: Completed
• Phase: N/A
• First received: January 24, 2018
• Last updated: February 3, 2018
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Excessive Iodine Status
• Infant, Newborn, Diseases
• Neonatal Disorder
• Pregnancy Related
• Thyroid Dysfunction, Antepartum

Intervention

Other:
• Dietary 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

References & Publications (8)

Alexander EK, Pearce EN, Brent GA, Brown RS, Chen H, Dosiou C, Grobman WA, Laurberg P, Lazarus JH, Mandel SJ, Peeters RP, Sullivan S. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy — View Citation

Kaneshige T, Arata N, Harada S, Ohashi T, Sato S, Umehara N, Saito T, Saito H, Murashima A, Sago H. Changes in serum iodine concentration, urinary iodine excretion and thyroid function after hysterosalpingography using an oil-soluble iodinated contrast me — View Citation

Mekaru K, Kamiyama S, Masamoto H, Sakumoto K, Aoki Y. Thyroid function after hysterosalpingography using an oil-soluble iodinated contrast medium. Gynecol Endocrinol. 2008 Sep;24(9):498-501. doi: 10.1080/09513590802246364. — View Citation

Omoto A, Kurimoto C, Minagawa M, Shozu M. A case of fetal goiter that resolved spontaneously after birth. J Clin Endocrinol Metab. 2013 Oct;98(10):3910-1. doi: 10.1210/jc.2013-1066. Epub 2013 Aug 26. — View Citation

Satoh M, Aso K, Katagiri Y. Thyroid Dysfunction in Neonates Born to Mothers Who Have Undergone Hysterosalpingography Involving an Oil-Soluble Iodinated Contrast Medium. Horm Res Paediatr. 2015;84(6):370-5. doi: 10.1159/000439381. Epub 2015 Sep 25. — View Citation

So S, Yamaguchi W, Tajima H, Nakayama T, Tamura N, Kanayama N, Tawara F. The effect of oil and water-soluble contrast medium in hysterosalpingography on thyroid function. Gynecol Endocrinol. 2017 Sep;33(9):682-685. doi: 10.1080/09513590.2017.1307960. Epub — View Citation

Sun D, Codling K, Chang S, Zhang S, Shen H, Su X, Chen Z, Scherpbier RW, Yan J. Eliminating Iodine Deficiency in China: Achievements, Challenges and Global Implications. Nutrients. 2017 Apr 5;9(4). pii: E361. doi: 10.3390/nu9040361. Review. — View Citation

Xiao Y, Sun H, Li C, Li Y, Peng S, Fan C, Teng W, Shan Z. Effect of Iodine Nutrition on Pregnancy Outcomes in an Iodine-Sufficient Area in China. Biol Trace Elem Res. 2017 Aug 2. doi: 10.1007/s12011-017-1101-4. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of adverse pregnancy outcome	prevalence of stillbirth, abortion and other adverse pregnancy outcome	6-9 months post identification of maternal iodine excess
Primary	composite neonatal outcome	Apgar scores, birth weight of the neonates,and prevalence of thyroid dysfunction in neonates	6-9 months post identification of maternal iodine excess
Secondary	prevalence of maternal thyroid dysfunction in pregnancy	Laboratory 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.	through study completion, about 6-9 months post identification of maternal iodine excess
Secondary	prevalence of neonatal iodine excess	urinary 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.	within 1 week after birth