evothyroxine for euthyroid women with recurrent miscarriage and positive TPO antibodies: a randomized controlled trial
- Conditions
- recurrent miscarriagethyroid autoimmunity1004373910000211
- Registration Number
- NL-OMON44997
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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