NL-OMON44997已完成3 期
evothyroxine for euthyroid women with recurrent miscarriage and positive TPO antibodies: a randomized controlled trial - T4LIFE-trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Women with unexplained RM and thyroid autoimmunity. Recurrent miscarriage is defined as two or more miscarriages.TPOAb positivity is defined according to the cut off levels of the coordinating or cooperating centres.
- •2.Age 18 - 42 years at randomisation
- •3.Willing and able to give informed consent (IC).
排除标准
- •1.Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies [IgG or IgM]) and/ or B2-Glycoprotein IgG or IgM)
- •2.Other auto-immune conditions, diabetes mellitus, diabetes gravidarum, thyroid disease different then isolated thyroid autoimmunity.
- •3. Abnormal TSH. This is defined as a TSH level different then the centre specific cut- off levels. ( Known thyroid disease different then isolated thyroid autoimmunity)
- •4.Previous enrolment in the T4LIFE- trial
- •5. Contraindications to levothyroxine use:
- •Adrenal or pituitary disorders, untreated
- •Thyreotoxicosis, untreated
- •Acute cardiac arrest
- •Acute pancreatitis
- •Acute myocarditis
研究者
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