Research on Excessive Iodine Status in Pregnancy

NCT03422406 | Completed

• 1 other identifier: Liuyanping
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• prevalence of adverse pregnancy outcome

  prevalence of stillbirth, abortion and other adverse pregnancy outcome

  6-9 months post identification of maternal iodine excess

• 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 Outcomes (2)

• prevalence of maternal thyroid dysfunction in pregnancy

  through study completion, about 6-9 months post identification of maternal iodine excess

• prevalence of neonatal iodine excess

  within 1 week after birth

Study Arms (2)

HH group

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

Other: Dietary iodine intake restriction

Non-HH group

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

Other: Dietary iodine intake restriction

Interventions

Dietary iodine intake restriction 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.

HH group; Non-HH group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All enrolled pregnant women will be from urban area of Beijing, whose dietary iodine intake and pre-gestational history of iodine exposure will be reviewd in detail.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (8)

• 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.

  PMID: 28379180 RESULT

• 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.

  PMID: 28056690 RESULT

• 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.

  PMID: 28770411 RESULT

• 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.

  PMID: 28412871 RESULT

• 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.

  PMID: 25546154 RESULT

• 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.

  PMID: 26402613 RESULT

• 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.

  PMID: 18958768 RESULT

• 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.

  PMID: 23979952 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine for urinary iodine concentration analysis;serum for serum iodine concentration analysis; maternal breast milk for colostrum iodine concentration analysis

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xuan Zhang, MD

  Department of academic research,Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 5, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 6, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share