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

NCT05677581 | Unknown

• 1 other identifier: SF2022-2-2029
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Function; Iodine Nutrition Status

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

pregnancy and lactation period women

Other: iodine nutrition status

healthy women of childbearing age

Other: iodine nutrition status

Interventions

iodine nutrition status OTHER

iodine nutrition status

healthy women of childbearing age; pregnancy and lactation period women

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

maternal and women of childbearing age in Beijing area

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital ,Capital Medical University

Beijing, China

RECRUITING

Central Study Contacts

Yan Long, Chief Physician/Professor

CONTACT

13671148911; longyan_doc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: January 10, 2023
• Study Start: November 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)