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

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: Thyroid Function; Iodine Nutrition Status
• Intervention / Treatment: Other: iodine nutrition status

• Study Type: Observational
• Enrollment (Estimated): 2100

Contacts and Locations

• 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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

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	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	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	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	detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary	6 weeks after parturition

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

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: Endocrine System Diseases; Thyroid Diseases
• 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