Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

Pregnancy Clinical Trial

Official title:

Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586220
• Other study ID #: XHEC-C-2015-003-2
• Status: Completed
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status.Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Description:

Background: Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status. Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Design: prospective cohort study

Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected to participate in the study.The investigators collect the spot urine samples(n=750) once every two weeks.

Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes (28-32 weeks' gestation) and their newborns were selected to participate the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 35 Years

Eligibility

Inclusion Criteria:

• 22-35 years,

• 28-32 weeks' gestation,

Exclusion Criteria:

• a known history of thyroid disease in the non-pregnant state and previous.

Related Conditions & MeSH terms

• Iodine Deficiency
• Pregnancy

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
qingya tang

Country where clinical trial is conducted

China, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary iodine (UI) concentrations		up to three months
Secondary	thyroid stimulating hormone level of newborns		up to three months
Secondary	daily iodine intake of pregnant women	Daily iodine intake was estimated using the total diet study approach	up to three months