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Purpose:   To investigate the effect of subclinical hypothyroidism on pregnancy outcomes of women early in their pregnancy with different thyroid-stimulating hormone levels and thyroid peroxidase antibody–negative status and to explore reasonable thyroid-stimulating hormone levels for subclinical hypothyroidism in early pregnancy.Methods:   A total of 2378 women early in their pregnancy were studied retrospectively. The baseline characteristics were collected from medical records. Pregnancy outcomes were compared between the euthyroidism and subclinical hypothyroidism groups that were diagnosed by 2011 or 2017 American Thyroid Association guidelines. In addition, the effect of different maternal thyroid-stimulating hormone levels on adverse pregnancy outcomes was analyzed using binary logistic regression.Results:   According to the 2011 American Thyroid Association diagnostic criteria of subclinical hypothyroidism, the prevalence of pregnancy outcomes was not significantly higher in the subclinical hypothyroidism group than in the euthyroidism group. However, pregnant women with subclinical hypothyroidism identified by the 2017 American Thyroid Association criteria had a higher risk of premature delivery (odds ratio = 3.93; 95% confidence interval = 1.22–12.64), gestational diabetes mellitus (odds ratio = 2.69; 95% confidence interval = 1.36–5.32), and gestational anemia (odds ratio = 3.28; 95% confidence interval = 1.60–6.75). Moreover, no differences in the prevalence of adverse pregnancy outcomes were observed between the mildly elevated thyroid-stimulating hormone group (2.5 &lt; thyroid-stimulating hormone ⩽4.0 mIU/l) and the normal thyroid-stimulating hormone group (0.27 &lt; thyroid-stimulating hormone ⩽2.5 mIU/l). The significantly elevated thyroid-stimulating hormone group (4.0 &lt; thyroid-stimulating hormone &lt; 10.0 mIU/l) had a higher prevalence of premature delivery, gestational diabetes mellitus, and gestational anemia than the normal thyroid-stimulating hormone group, even after controlling for potential confounding factors.Conclusion:   A mildly elevated thyroid-stimulating hormone level or maternal subclinical hypothyroidism diagnosed by 2011 American Thyroid Association guidelines during early pregnancy in thyroid peroxidase antibody–negative women was not associated with adverse pregnancy outcomes. However, maternal subclinical hypothyroidism identified by the 2017 American Thyroid Association guidelines increased the risks of several adverse pregnancy outcomes in women untreated with levothyroxine. The 2017 American Thyroid Association guidelines could be more reasonable for the diagnosis of subclinical hypothyroidism in southern China.

Impact of TPOAb-negative maternal subclinical hypothyroidism in early pregnancy on adverse pregnancy outcomes