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

Thyroid Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677581
• Other study ID #: SF2022-2-2029
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Beijing Friendship Hospital
• Contact: Yan Long, Chief Physician/Professor
• Phone: 13671148911
• Email: longyan_doc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Function

Intervention

Other:
• iodine nutrition status
iodine nutrition status

Locations

Country	Name	City	State
China	Beijing Friendship Hospital ,Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Data of postpartum women	detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary	6 weeks after parturition