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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03422406
Other study ID # Liuyanping
Secondary ID
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
Health authority
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.

Study Design


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
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