Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

Completed

• Conditions: Pregnancy; Iodine Deficiency

• Registration Number: NCT02586220
• Lead Sponsor: qingya tang

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• 22-35 years,
• 28-32 weeks' gestation,

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urinary iodine (UI) concentrations	up to three months

Secondary Outcome Measures

Name	Time	Method
thyroid stimulating hormone level of newborns	up to three months
daily iodine intake of pregnant women	up to three months	Daily iodine intake was estimated using the total diet study approach

Trial Locations

Locations (2)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine; 🇨🇳 Shanghai, Shanghai, China

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China