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临床试验/EUCTR2011-000719-19-GB
EUCTR2011-000719-19-GB进行中(未招募)1 期

A Randomised Controlled Trial of the Efficacy and Mechanism of Levothyroxine Treatment on Pregnancy and Neonatal Outcomes in Women with Thyroid Antibodies. (TABLET: Thyroid AntiBodies and LEvoThyroxine Study) - TABLET

niversity of Birmingham0 个研究点目标入组 952 人开始时间: 2011年3月15日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
952

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • 1. Women trying to conceive 2. History of one or more miscarriage(s)or primary/secondary infertility 3. Age 16 - 40 years at randomisation. 4. Biochemically euthyroid (Free T4 and TSH within specified reference ranges) 5. Thyroid Peroxidase Antibody (TPO) positive 6. Willing and able to give written informed consent
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 900
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • 1. Current or past treatment for thyroid disease. 2. Contraindication to levothyroxine treatment. -Thyrotoxicosis. Hypersensitivity to any components tablets. 3. Women taking amiodarone or lithium therapy. 3. Participants in any other blinded, placebo controlled trials on Investigational Medicinal Products in pregnancy. 4. Participants with previous or current cardiac disease.

研究者

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Thyroid AntiBodies and LEvoThyroxine Study | 临床试验