The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women

Study Overview
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Brief Summary
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A descriptive analysis involving 300 healthy pregnant women to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range.

Detailed Description
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A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.

Official Title
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The Establish of Trimester-specific Reference Ranges for Thyroid Tests in Pregnant Women and the Influence of Thyroid Disorders on Pregnancy and Its Outcomes.

Conditions
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Diseases Pregnancy Thyroid

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The people who lived in the city more than five years, aged between 19 and 45, or the single pregnancy women who registered or checked in Peking University international hospital would be enrolled. The pregnancy confirmed by the ultrasound or blood HCG test. In order to build a pregnancy reference range of normal pregnant women who must meet the NACB standard. Exclusion Criteria: The history of thyroid disorders. Goiter. Oral contraceptives or any drugs affected the function of thyroid. With other chronic autoimmune disease, malignant tumor, blood disease, etc Twin pregnancies and multiple pregnancies

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy pregnant women<br>A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. | |
| Normal pregnant population<br>According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy. | Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of thyroid disorders on pregnancy. | Pregnant women:subclinical hypothyroidism,hypertension of pregnancy, eclampsia gravidarum, gestational diabetes mellitus, abortion, stillbirth. | up to 2 years | 
| The influence of thyroid disorders its outcomes. | Newborn:neonatal death,neonatal respiratory distress syndrome, low birth weight, macrosomia,et al. | up to 2 years |