Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

March 24, 2020 updated by: qingya tang
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Xinhua hospital
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

250 pregnant women recruited from antenatal outpatient clinics in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, China.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
normal pregnant women
150 normal pregnant women (28-32 weeks' gestation)
pregnant women with gestational
100 pregnant women with gestational diabetes (28-32 weeks' gestation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urinary iodine (UI) concentrations
Time Frame: up to three months
up to three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thyroid stimulating hormone level of newborns
Time Frame: up to three months
up to three months
daily iodine intake of pregnant women
Time Frame: up to three months
Daily iodine intake was estimated using the total diet study approach
up to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

qingya tang

Investigators

  • Principal Investigator: Qingya Tang, MMed, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • XHEC-C-2015-003-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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