Thyroid AntiBodies and LEvoThyroxine study (TABLET)

Phase 3

Completed

• Conditions: Reproductive health, childbirth; Pregnancy and Childbirth; Spontaneous abortion

• Registration Number: ISRCTN15948785
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30907987

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-31
• Study Completion: 2017-05-15
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 952

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)
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

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified