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Completed

NCT Number: NCT02586220

Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

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.

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Key information

Conditions

Pregnancy Iodine Deficiency

Age range

22 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Xinhua Hospital, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. urinary iodine (UI) concentrations

    Time frame: up to three months

Secondary outcomes

  1. thyroid stimulating hormone level of newborns

    Time frame: up to three months

  2. daily iodine intake of pregnant women

    Time frame: up to three months

    Daily iodine intake was estimated using the total diet study approach

Sponsors and collaborators

Lead sponsor

qingya tang

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2015
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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