## Protocol Section
### Identification Module
**NCT ID:** NCT00505479

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

#### Organization Study ID Info
**ID:** G20020584
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang University
### Status Module
#### Completion Date
**Date:** 2010-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2007-07-23

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-07-20

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2007-05

**Status Verified Date:** 2007-07

#### Study First Post Date
**Date:** 2007-07-23
**Type:** ESTIMATED
**Study First Submit Date:** 2007-07-20
**Study First Submit QC Date:** 2007-07-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhejiang University

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Congenital Hypothyroidism

- Pregnancy

- Iodine Deficiency

**Keywords:**

- Congenital Hypothyroidism

- pregnancy

- iodine

- deficiency

### Design Module

#### Design Info

**Time Perspective:** PROSPECTIVE

**Study Type:** OBSERVATIONAL

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Pregnant women in Zhejiang province (and their newborns)

Exclusion Criteria:

* Endocrine disease

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhaozy@zju.edu.cn

**Name:** Zhengyan Zhao, M.D.

**Phone:** 008657187061007

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** zhaozy@zju.edu.cn

- **Name:** Zhengyan Zhao, M.D.

- **Phone:** 008657187061007

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zhengyan Zhao, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Children's Hospital Zhejiang University School of Medicine

**State:** Zhejiang

**Status:** RECRUITING

**Zip:** 310003

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Hospital Zhejiang University School of Medicine

**Name:** zhengyan Zhao, M.D.

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013959

- Term: Thyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000004392

- Term: Dwarfism

- ID: D000001848

- Term: Bone Diseases, Developmental

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000001849

- Term: Bone Diseases, Endocrine

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10087

- Name: Hypothyroidism

- Relevance: HIGH

- As Found: Hypothyroidism

- ID: M6623

- Name: Congenital Hypothyroidism

- Relevance: HIGH

- As Found: Congenital Hypothyroidism

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7566

- Name: Dwarfism

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5127

- Name: Bone Diseases, Developmental

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5128

- Name: Bone Diseases, Endocrine

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T1512

- Name: Congenital Hypothyroidism

- Relevance: HIGH

- As Found: Congenital Hypothyroidism

### Condition Browse Module - Meshes

- ID: D000003409

- Term: Congenital Hypothyroidism

- ID: D000007037

- Term: Hypothyroidism

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M229695

- Name: Cadexomer iodine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
