ISRCTN15948785
Completed
Phase 3
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 sites952 target enrollmentOctober 31, 2011
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Birmingham (UK)
- Enrollment
- 952
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30907987
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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