Clinical trial NCT05677581: Longitudinal Study on the Influence of Iodine Nutrition Status on Thyroid Function of Childbearing Age Women During Pregnancy and 6 Weeks Postpartum
Official title: Longitudinal Study on the Influence of Iodine Nutrition Status on Thyroid Function of Childbearing Age Women During Pregnancy and 6 Weeks Postpartum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Function
Iodine Nutrition Status
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 2100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: maternal and women of childbearing age in Beijing area

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.


Eligibility 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

Primary outcomes:
measure: Data of pregnant women in the early trimester of pregnancy
timeFrame: Any day between weeks 8 and 12 of gestation
measure: Data of pregnant women in the middle trimester of pregnancy
timeFrame: Any day between weeks 24 and 28 of gestation
measure: Data of pregnant women in the third trimester of pregnancy
timeFrame: Any day between weeks 36 of gestation to the day before parturition
measure: Data of postpartum women
timeFrame: 6 weeks after parturition
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital ,Capital Medical University
Study officials:
References: