Research on Excessive Iodine Status in Pregnancy

NCT ID: NCT03422406

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Excessive Iodine Status Thyroid Dysfunction, Antepartum Pregnancy Related Neonatal Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HH group

Group (participants) with pre-gestational history of undergoing hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium

Dietary iodine intake restriction

Intervention Type OTHER

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.

Non-HH group

Group (participants) without pre-gestational history of undergoing hysterosalpingography (HSG)

Dietary iodine intake restriction

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xuan Zhang, MD

Role: STUDY_CHAIR

Department of academic research,Peking Union Medical College Hospital

References

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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):361. doi: 10.3390/nu9040361.

Reference Type RESULT
PMID: 28379180 (View on PubMed)

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 and the Postpartum. Thyroid. 2017 Mar;27(3):315-389. doi: 10.1089/thy.2016.0457.

Reference Type RESULT
PMID: 28056690 (View on PubMed)

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. 2018 Apr;182(2):231-237. doi: 10.1007/s12011-017-1101-4. Epub 2017 Aug 2.

Reference Type RESULT
PMID: 28770411 (View on PubMed)

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 2017 Apr 17.

Reference Type RESULT
PMID: 28412871 (View on PubMed)

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 medium (lipiodol). J Clin Endocrinol Metab. 2015 Mar;100(3):E469-72. doi: 10.1210/jc.2014-2731. Epub 2014 Dec 29.

Reference Type RESULT
PMID: 25546154 (View on PubMed)

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.

Reference Type RESULT
PMID: 26402613 (View on PubMed)

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.

Reference Type RESULT
PMID: 18958768 (View on PubMed)

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. No abstract available.

Reference Type RESULT
PMID: 23979952 (View on PubMed)

Other Identifiers

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Liuyanping

Identifier Type: -

Identifier Source: org_study_id

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