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Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?

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ClinicalTrials.gov Identifier: NCT00505479
Recruitment Status : Unknown
Verified July 2007 by Zhejiang University.
Recruitment status was:  Recruiting
First Posted : July 23, 2007
Last Update Posted : July 23, 2007
Sponsor:
Information provided by:
Zhejiang University

July 20, 2007
July 23, 2007
July 23, 2007
May 2007
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No Changes Posted
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Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?
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Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function.

Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function.

Healthy women at 12 weeks’ gestation and over from four different areas in Zhejiang province were enrolled to participate this program from May 2007 to May 2010. Women consented to provide urine samples and salt samples during pregnancy (12, 16, 24 weeks’ gestation and before delivery), and give permission to access their newborn’s TSH value. Urinary iodine concentration (UIC) was determined by ammonium persulfate digestion microplate method, and TSH was determined by a time resolved fluoro-immunoassay (TRFIA). The diagnostic standard for congenital hypothyroidism was: TSH ≥ 20 mU/L and declined FT4 levels. Compare the correlation to effects with different level of iodine content in salt, maternal UIC and neonatal TSH. Investigate the optimal level of iodine content in salt in different areas in ZheJiang province.

Observational
Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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  • Congenital Hypothyroidism
  • Pregnancy
  • Iodine Deficiency
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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May 2010
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Inclusion Criteria:

  • Pregnant women in Zhejiang province (and their newborns)

Exclusion Criteria:

  • Endocrine disease
Sexes Eligible for Study: Female
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00505479
G20020584
Yes
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Zhejiang University
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Study Director: zhengyan Zhao, M.D. Children's Hospital Zhejiang University School of Medicine
Zhejiang University
July 2007