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Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

Sponsor
qingya tang (Other)
Overall Status
Completed
CT.gov ID
NCT02586220
Collaborator
(none)
250
Enrollment
2
Locations
11
Actual Duration (Months)
125
Patients Per Site
11.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Iodine Nutrition During Pregnancy and Related Neonatal Physical Development
    Actual Study Start Date :
    Aug 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. urinary iodine (UI) concentrations [up to three months]

    Secondary Outcome Measures

    1. thyroid stimulating hormone level of newborns [up to three months]

    2. daily iodine intake of pregnant women [up to three months]

      Daily iodine intake was estimated using the total diet study approach

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 22-35 years,

    • 28-32 weeks' gestation,

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine Shanghai Shanghai China 200092
    2 Xinhua Hospital Shanghai Shanghai China 200092

    Sponsors and Collaborators

    • qingya tang

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    qingya tang, Chief Physician, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02586220
    Other Study ID Numbers:
    • XHEC-C-2015-003-2
    First Posted:
    Oct 26, 2015
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Mar 25, 2020