Longitudinal Study on the Influence of Iodine Nutrition Status on Thyroid Function of Childbearing Age Women During Pregnancy and 6 Weeks Postpartum

May 8, 2024 updated by: Beijing Friendship Hospital

The goal of this observational study is to provide a reference for formulating individual appropriate iodine intake programs for women during pregnancy and postpartum and improving the monitoring and evaluation system of maternal iodine nutrition status. The main questions it aims to answer are:

  • To analyse the longitudinal changes of urinary iodine, urinary iodine/creatinine ratio, thyroid function and related factors in different periods of early, middle, late pregnancy and 6 weeks postpartum in Beijing area.
  • To explore the relationship between iodine nutrition status and the changes of thyroid function and to further clarify the effect of iodine nutrition status on thyroid function of women of childbearing age during pregnancy and postpartum in combination with dietary intake of iodine questionnaire.

Participants will be detected there thyroid function, the level of median urinary iodine and urinary iodine/creatinine.

Researchers will compare healthy women of childbearing age served as the control group in the same period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2100

Contacts and Locations

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

Study Contact

  • Name: Yan Long, Chief Physician/Professor
  • Phone Number: 13671148911
  • Email: longyan_doc@163.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital ,Capital Medical University
        • Contact:
          • Lei Yang

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

maternal and women of childbearing age in Beijing area

Description

8-12 weeks healthy maternal:

Inclusion Criteria:

  • primigravida
  • no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases before pregnancy
  • no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases before pregnancy
  • no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases before pregnancy

Exclusion Criteria:

  • multiple pregnancies and multigravida
  • a history of type I or type II diabetes before pregnancy
  • a clear history of thyroid diseases before pregnancy
  • taking drugs that affect thyroid function and/or blood sugar before or during early pregnancy

Healthy women of childbearing age:

Inclusion Criteria:

  • 20-40 years old
  • no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases
  • no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases
  • no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases

Exclusion Criteria:

  • a history of type I or type II diabetes
  • a clear history of thyroid diseases
  • taking drugs that affect thyroid function and/or blood sugar

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
Intervention / Treatment
pregnancy and lactation period women
Other: iodine nutrition status
iodine nutrition status
healthy women of childbearing age
Other: iodine nutrition status
iodine nutrition status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data of pregnant women in the early trimester of pregnancy
Time Frame: Any day between weeks 8 and 12 of gestation
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary iodine and urinary iodine/creatinine
Any day between weeks 8 and 12 of gestation
Data of pregnant women in the middle trimester of pregnancy
Time Frame: Any day between weeks 24 and 28 of gestation
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Any day between weeks 24 and 28 of gestation
Data of pregnant women in the third trimester of pregnancy
Time Frame: Any day between weeks 36 of gestation to the day before parturition
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
Any day between weeks 36 of gestation to the day before parturition
Data of postpartum women
Time Frame: 6 weeks after parturition
detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary
6 weeks after parturition

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

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)

November 15, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF2022-2-2029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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