An observational study in Postpartum Thyroiditis, sponsored by China National Nuclear Corporation 416 Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-23.
Sponsored by China National Nuclear Corporation 416 Hospital · Observational
At present, attention to thyroid disease during pregnancy is increasing at home and abroad, but there is relatively little concern about postpartum thyroid disease, especially high incidence of postpartum thyroiditis (PPT). This observational study is to investigate the relationship between different levels of thyroid peroxidase antibody (TPOAb) and postpartum thyroiditis (PPT) in early pregnancy (1-12 weeks of pregnancy), and to explore whether PPT can be predicted by different TPOAb levels. According to the TPOAb level in early pregnancy, the postpartum of pregnant women was followed up, PPT was detected early, and intervention was performed according to thyroid dysfunction.
First pregnant women who between the ages of 18 to 35 years old and normal thyroid function before pregnancy were selected. Recruit 300 pregnant women who early pregnancy (1-12 weeks of pregnancy) screening TPOAb positive and normal Free triiodothyronine (FT3), normal free thyroxine (FT4) ,Thyroid Stimulating Hormone (TSH) \<4.78mIU / L as the observation group. They will be divided into low-level group (TPOAb at 34-102 IU/ml), medium-level group (TPOAb at 103-204 IU/ml), and high-level group (TPOAb>205) according to TPOAb. Recruit 100 pregnant women who early pregnancy (1-12 weeks of pregnancy) screening TPOAb negative and normal FT3, normal FT4,TSH \<4.78mIU / L as the Control group.
Thyroid function (FT3, FT4, TSH) and TPOAb, thyroglobulin antibody(TgAb) ,thyroid hormone receptor antibody(TRAb) will be screened in the observation group and the control group at 3 months, 6 months, and 12 months after delivery. If the mother is diagnosed with postpartum thyroiditis (PPT), continue to screen for thyroid function (FT3, FT4, TSH) and thyroid antibodies (TPOAb, TRAb, TgAb) 18 months after delivery. The correlation between the early pregnancy TPOAb level and postpartum thyroiditis was analyzed between the observation group and the control group and the observation group. It was explored whether the occurrence of postpartum thyroiditis (PPT) can be predicted according to the TPOAb level in the first trimester. And targeted maternal effective follow-up and timely intervention to treat PPT provide important basis.
300 pre-pregnancy tests for thyroid function (FT3, FT4, TSH) were normal, initial pregnancy under 30 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3, FT4, TSH \<4.78 mIU/L Females were observed and divided into low-level groups (TPOAb at 34-102 IU/ml), medium-level groups (TPOAb at 103-204 IU/ml), and high-level groups (TPOAb > 205 IU/ml) according to TPOAb.
100 cases. 100 pre-pregnancy tests for thyroid function (FT3, FT4, TSH) and normal antibodies, first pregnancy under 30 years old, early pregnancy (1-12 weeks of pregnancy), initial screening for thyroid-related antibody negative and thyroid function: FT3, FT4 normal, TSH\<4.78 Healthy women with mIU/L were the control group.
Observation group:
Control group:
Exclusion Criteria:
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3 and FT4, TSH\<4.78mIU/L，TPOAb at 34-102 IU/ml.
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3 and FT4, TSH\<4.78mIU/L，TPOAb at 103-204 IU/ml.
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3 and FT4, TSH\<4.78mIU/L，TPOAb \>205IU/ml.
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of negative Thyroid antibody, thyroid function: normal FT3 and FT4, TSH\<4.78mIU/L.
Measure the incidence rate of PPT in different TPOAb levels in early pregnancy.
The levels of TPOAb include:Low level of TPOAb(34-102 IU/ml),Medium level of TPOAb(103-204 IU/ml),High level of TPOAb(\>205IU/m), TPOAb negative.
Time frame: 22 months
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Postpartum Thyroiditis