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  • Title: Increased pregnancy loss rate in thyroid antibody negative women with TSH levels between 2.5 and 5.0 in the first trimester of pregnancy.
    Author: Negro R, Schwartz A, Gismondi R, Tinelli A, Mangieri T, Stagnaro-Green A.
    Journal: J Clin Endocrinol Metab; 2010 Sep; 95(9):E44-8. PubMed ID: 20534758.
    Abstract:
    CONTEXT: The definition of what constitutes a normal TSH during pregnancy is in flux. Recent studies suggested that the first trimester upper limit of normal for TSH should be 2.5 mIU/liter. OBJECTIVE: The objective of the study was to evaluate the pregnancy loss and preterm delivery rate in first-trimester thyroid peroxidase antibody-negative women with TSH values between 2.5 and 5.0 mIU/liter. DESIGN: The present study is a component of a recently published large-scale prospective trial that evaluated the impact of levothyroxine treatment on maternal and neonatal complications in thyroid peroxidase-positive women with TSH levels above 2.5 mIU/liter. The present study evaluated 4123 thyroid peroxidase antibody-negative women with TSH levels at or below 5.0 mIU/liter. Women were divided into two groups based on their initial TSH: group A, TSH level below 2.5 mIU/liter, excluding hyperthyroid women defined as an undetectable TSH with an elevated free T(4), and group B, TSH level between 2.5 and 5.0 mIU/liter. SETTING: The study was conducted at two ambulatory clinics of community hospitals in southern Italy. PATIENTS: A total of 4123 women were evaluated. INTERVENTION: There was no intervention. MAIN OUTCOME MEASURES: The incidence of pregnancy loss and preterm delivery in group A as compared with group B was measured. RESULTS: The rate of pregnancy loss was significantly higher in group B as compared with group A (6.1 vs. 3.6% respectively, P = 0.006). There was no difference in the rate of preterm delivery between the two groups. CONCLUSIONS: The increased incidence of pregnancy loss in pregnant women with TSH levels between 2.5 and 5.0 mIU/liter provides strong physiological evidence to support redefining the TSH upper limit of normal in the first trimester to 2.5 mIU/liter.
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