JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Effects of Levothyroxine on Pregnant Women With Subclinical Hypothyroidism, Negative for Thyroid Peroxidase Antibodies

Sima Nazarpour, Fahimeh Ramezani Tehrani, Masoumeh Simbar, Maryam Tohidi, Sonia Minooee, Maryam Rahmati, Fereidoun Azizi
Journal of Clinical Endocrinology and Metabolism 2018 March 1, 103 (3): 926-935
29126290

Context: Currently, there is no consensus on universal thyroid screening and levothyroxine (LT4) treatment of pregnant women with subclinical hypothyroidism (SCH) who are negative for thyroid peroxidase antibody (TPOAb-).

Objective: We aimed to evaluate the benefits of LT4 treatment on pregnancy outcomes in SCH-TPOAb- women.

Design: This study was conducted within the framework of the Tehran Thyroid and Pregnancy Study. A single-blind randomized clinical trial was undertaken in pregnant women who were SCH-TPOAb-.

Setting: Prenatal care centers of the Shahid Beheshti University of Medical Sciences.

Patients: Using the thyrotropin (TSH) cut point of 2.5 mIU/L, 366 SCH-TPOAb- and 1092 euthyroid TPOAb- women were recruited.

Intervention: SCH-TPOAb- women were randomly assigned to two groups: group A (n = 183) who were treated with LT4 and group B (n = 183) who received no treatment. A total of 1,028 euthyroid TPOAb- women served as the control group (group C).

Main Outcome Measure: The primary outcome was the rate of preterm delivery.

Results: Using the TSH cutoff of 2.5 mIU/L, no significant difference in preterm delivery was observed between groups A and B [relative risk (RR): 0.86; 95% confidence interval (CI): 0.47 to 1.55; P = 0.61]. However, log-binomial model analysis based on a cut point of 4.0 mIU/L demonstrated a significantly lower rate of preterm delivery in LT4-treated women compared with those who received no treatment (RR: 0.38; 95% CI: 0.15 to 0.98; P = 0.04).

Conclusions: Despite no beneficial effect of LT4 therapy in reducing preterm delivery in SCH-TPOAb- women with a TSH cut point of 2.5 to 4 mIU/L, LT4 could precisely decrease this complication using the newly recommended cutoff ≥4.0 mIU/L.

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