Condition category
Pregnancy and Childbirth
Date applied
31/10/2011
Date assigned
31/10/2011
Last edited
29/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Arri Coomarasamy

ORCID ID

Contact details

Clinical Reader in Reproductive Medicine and Gynaecology
Academic Department
3rd Floor Birmingham Women’s Hospital
Metchley Park Road
Edgbaston
Birmingham
B15 2TG
United Kingdom
+44 (0)121 623 6805
a.coomarasamy@bham.ac.uk

Additional identifiers

EudraCT number

2011-000719-19

ClinicalTrials.gov number

Protocol/serial number

11051

Study information

Scientific title

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

Acronym

TABLET

Study hypothesis

Current study hypothesis as of 29/04/2013:
Levothyroxine will assist women aged 16-40 with a history of one or more miscarriage or who are being treated for infertility, who have been identified as having thyroid antibodies (TPO antibody positive) trying to conceive within 1 year of miscarriage.

Previous study hypothesis until 29/04/2013:
Levothyroxine will assist women aged 16-40 with a history of one or more miscarriage, who have been identified as having thyroid antibodies (TPO antibody positive) trying to conceive within 1 year of miscarriage.

Please note that as of 29/04/2013, the anticipated end date for this trial was updated from 31/12/2013 to 31/10/2015

Ethics approval

ref: 11/SW/0036

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Reproductive health, childbirth

Intervention

Current interventions as of 29/04/2013:
Women aged 16-40 with a history of one or more miscarriage or who are being treated for infertility, who have been identified as having thyroid antibodies (TPO antibody positive), and will be trying to conceive within 1 year.

Prevous interventions until 29/04/2013:
Women aged 16-40 with a history of one or more miscarriage, who have been identified as having thyroid antibodies (TPO antibody positive), and will be trying to conceive within 1 year of miscarriage.

Levothyroxine, 50mcg Levothyroxine, overencapsulated to be taken orally daily versus placebo, to match investigational medicinal products (IMP). Followed Up at 21 month(s)

Intervention type

Drug

Phase

Phase III

Drug names

Levothyroxine

Primary outcome measures

Live birth measured at beyond 34 weeks gestational age

Secondary outcome measures

Added as of 29/04/2013:
1. Gestation at delivery
2. Conception (urinary pregnancy) rate
3. Clinical pregnancy at 6 – 8 weeks
4. On-going pregnancy at 11-13 weeks
5. Miscarriage (delivery before 24 weeks of gestation)
6. Survival at 28 days of neonatal life
7. Thyroid function tests

Overall trial start date

10/10/2011

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 900; UK Sample Size: 900

Participant 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

Recruitment start date

10/10/2011

Recruitment end date

31/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Reader in Reproductive Medicine and Gynaecology
Birmingham
B15 2TG
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Birmingham Clinical Trials Unit
Division of Medical Sciences
Robert Aitken Institute
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.bctu.bham.ac.uk/

Funders

Funder type

Government

Funder name

NIHR - Efficacy and Mechanism Evaluation Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes