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

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Capital Medical University

Status

Enrolling

Conditions

Iodine Nutrition Status
Thyroid Function

Treatments

Other: iodine nutrition status

Study type

Observational

Funder types

Other

Identifiers

NCT05677581
SF2022-2-2029

Details and patient eligibility

About

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.

Enrollment

2,100 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,100 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Yan Long, Chief Physician/Professor

Data sourced from clinicaltrials.gov

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