Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study

Study Overview
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Brief Summary
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Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.

Detailed Description
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The investigators conducted a single-blinded trial in which pregnant women at a gestation of less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of thyrotropin, free thyroxine(FT4) and thyroid peroxidase antibody (TPOAb). Women were assigned to a screening group in PUMCH (in which measurements were obtained immediately) or a control group in HMCHH (in which serum was stored and measurements were obtained shortly after delivery). Each group enrolled 1000 pregnant women separately. Women with positive findings in the screening group were given individualized levothyroxine treatment and regular follow-up. Compare the pregnancy outcomes, IQ at 2-3 years of age in children of women with subclinical hypothyroidism between two groups.

Official Title
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Randomized Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study

Conditions
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Subclinical Hypothyroidism

Intervention / Treatment
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* Other: thyroid screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of the pregnant women who receive prenatal care in PUMCH and HMCHH Sign the consent form agree to follow-up the pregnancy outcome and child Exclusion Criteria: the pregnant women who do not agree to enter the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: the control group<br>The serum will be stored and the measurements will be obtained after the delivery | |
| Active Comparator: the thyroid screening group<br>The thyroid function and antibody will be measured during pregnancy. The subclinical hypothyroidism will be treated individually. | Other: thyroid screening<br>* The thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | the number of miscarriage，preeclampsia，gestational diabetes，prererm birth and postpartum hemorrhage | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antenatal thyroid screening, subclinical hypothyroidism, thyroid function, thyroid antibody, pregnancy outcome, childhood cognitive function