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临床试验/IRCT2013100114849N1
IRCT2013100114849N1已完成2 期

Assessment of the effect of Levothyroxine on pregnancy outcome in comparison with placebo in euthyroid pregnant women with positive thyroid peroxidase antibody

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 300 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
300

研究概览

简要总结

Background: Despite some studies indicating that thyroid antibody positivity during pregnancy has been associated with adverse pregnancy outcomes, evidence regarding the effects of levothyroxine (LT4) treatment of euthyroid/subclinical hypothyroid pregnant women with autoimmune thyroid disease on pregnancy outcome is limited. We aimed to assess whether pregnant women with autoimmune thyroid disease, but without overt thyroid dysfunction are affected by higher rates of adverse pregnancy outcomes. In addition, we aimed to explore whether LT4 treatment improves the pregnancy outcome of affected women.
Methods: A prospective study was carried out on pregnant women from the first trimester to delivery. The study was conducted among pregnant women receiving prenatal care in centers under coverage of Shahid Beheshti University of Medical Sciences. Of a total of 1746 pregnant women, screened for thyroid dysfunction, 1028 euthyroid TPOAb negative (TPOAb-) and 131 thyroid peroxidase antibody positive (TPOAb+) women without overt thyroid dysfunction entered the second phase of the study. TPOAb+ women were randomly divided into two groups: Group A (n= 65), treated with LT4 and group B (n= 66), received no treatment. The 1028 TPOAb- women (group C) served as a normal population control group. Primary outcomes were preterm delivery and miscarriage and secondary outcomes included placenta abruption, still birth, neonatal admission and neonatal TSH levels.
Results: Groups B and C displayed a lower rate of preterm deliveries compared with group A (RR=0.30, 95% CI: 0.1- 0.85, P=0.0229) and (RR= 0.23, 95% CI:0.14-0.40, P

研究设计

研究类型
Interventional

入排标准

年龄范围
15 years 至 49 years(—)
性别
Female

入选标准

  • pregnant women during the first 20 weeks of pregnancy.should not have contraindications for taking levothyroxine
  • contraindication of Levothyroxine include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension

排除标准

  • 未提供

研究者

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