Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?
|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
|Condition or disease|
|Congenital Hypothyroidism Pregnancy Iodine Deficiency|
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.
|Study Type :||Observational|
|Study Start Date :||May 2007|
|Estimated Study Completion Date :||May 2010|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505479
|Contact: Zhengyan Zhao, M.D.||firstname.lastname@example.org|
|Children's Hospital Zhejiang University School of Medicine||Recruiting|
|Hangzhou, Zhejiang, China, 310003|
|Contact: Zhengyan Zhao, M.D. 008657187061007 email@example.com|
|Principal Investigator: Zhengyan Zhao, M.D.|
|Study Director:||zhengyan Zhao, M.D.||Children's Hospital Zhejiang University School of Medicine|