A randomised controlled trial of the efficacy and mechanism of levothyroxine treatment on pregnancy and neonatal outcomes in women with thyroid antibodies

niversity of Birmingham (UK)0 个研究点目标入组 952 人开始时间: 2011年10月31日最近更新: 2020年6月8日

适应症

试验速览

•Current inclusion criteria as of 29/04/2013:
•1. Women trying to conceive
•2. History of one or more miscarriage(s) or who are being treated for 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
•Previous inclusion criteria until 29/04/2013:
•1. Women trying to conceive
•2. History of one or more miscarriage(s)
•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

•Current exclusion criteria as of 29/04/2013:
•1. Current or past treatment for thyroid disease
•2. Contraindication to levothyroxine treatment
•3. Thyrotoxicosis
•4. Hypersensitivity to any components tablets
•5. Women taking amiodarone or lithium therapy
•6. Participants in any other blinded, placebo controlled trials on Investigational Medicinal Products in pregnancy
•7. Previous or current diagnosis of cardiac disease
•Previous exclusion criteria until 29/04/2013:
•1. Current or past treatment for thyroid disease
•2. Contraindication to levothyroxine treatment
•3. Thyrotoxicosis
•4. Hypersensitivity to any components tablets
•5. Women taking amiodarone or lithium therapy
•6. Participants in any other blinded, placebo controlled trials on Investigational Medicinal Products in pregnancy
•7. Planning to conceive using ovulation stimulation therapy
•8. Previous or current diagnosis of cardiac disease

发起方

niversity of Birmingham (UK)