Miscarriage and Levothyroxine treatment in euthyroid spontaneously pregnant women with thyroid AntiBodies

ISRCTN ISRCTN76696359
DOI https://doi.org/10.1186/ISRCTN76696359
Secondary identifying numbers N/A
Submission date
27/04/2014
Registration date
21/05/2014
Last edited
10/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The body produces antibodies as part of a normal immune response to foreign invaders, like viruses and bacteria. Thyroid antibodies are antibodies targeted against the thyroid gland. Research suggests that women with thyroid antibodies experience an higher rate of miscarriage when compared to women without thyroid antibodies. The aim of this study is to find out whether early treatment with Levothyroxine increases the proportion of women who attain a live birth beyond 34 completed weeks of gestation by at least 50%.

Who can participate?
Women aged 18-40 in the first trimester of pregnancy with thyroid antibodies.

What does the study involve?
Patients are randomly assigned to one of two groups. One group is treated with Levothyroxine and the other group is left untreated.

What are the possible benefits and risks of participating?
There is no additional risk for untreated subjects; potential benefit for treated subjects.

Where is the study run from?
Vito Fazzi Hospital (Italy).

When is the study starting and how long is it expected to run for?
The study started in January 2011 and will run until December 2014.

Who is funding the study?
Vito Fazzi Hospital (Italy).

Who is the main contact?
Dr Roberto Negro
robnegro@tiscali.it

Contact information

Dr Roberto Negro
Scientific

Piazza F. Muratore, 1
Lecce
73100
Italy

Email robnegro@tiscali.it

Study information

Study designInterventional randomised single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMiscarriage and Levothyroxine treatment in euthyroid spontaneously pregnant women with thyroid Antibodies: an interventional randomised single-centre trial
Study acronymMiLAb
Study objectivesWe hypothesized that treatment with Levothyroxine in euthyroid spontaneously pregnant patients within the first trimester of pregnancy may reduce the rate of miscarriage.
Ethics approval(s)Institutional Review Board, 11/11/2010
Health condition(s) or problem(s) studiedChronic autoimmune thyroiditis in pregnancy
InterventionThe study involves first trimester pregnant women with positive TPOAb and/or TgAb and TSH <2.5 mIU/L. Patients are randomly assigned to two groups, one treated with Levothyroxine, and one left untreated.

Treated arm: patients with TSH 0.5-1.5mIU/L take 0.5 mcg/kg weight of Levothyroxine daily; patients with TSH 1.5-2.5 mIU/L take 1 mcg/Kg weight of Levothyroxine daily.

Untreated arm: patients with first trimester TSH 0.5-2.5mIU/L left untreated. TSH checked once in the second and once in the third trimester; if TSH >3.0mIU/L, patients are treated with Levothyroxine 1 mcg/kg pre-pregnancy weight daily.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Levothyroxine
Primary outcome measureNumber of miscarriages, defined as fetal death within 20 weeks of gestation. Time point is 20 weeks of gestation
Secondary outcome measuresNumber of preterm births, defined as birth before 37 complete weeks of gestation. Time point is end of pregnancy
Overall study start date01/01/2011
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit40 Years
SexFemale
Target number of participants175 patients for each arm (350 in total)
Total final enrolment590
Key inclusion criteria1. Women in the first trimester of pregnancy
2. Age 18-40
3. TSH: 0.5-2.5 mIU/L
4. FT4 in the normal range
5. Thyroid Peroxidase Antibody (TPO) positive
6. Willing and able to give informed consent
Key exclusion criteria1. Current or past treatment for thyroid disease
2. Contraindication to levothyroxine treatment
3. Drugs interfering with thyroid function
Date of first enrolment01/01/2011
Date of final enrolment31/12/2014

Locations

Countries of recruitment

  • Italy

Study participating centre

Piazza F. Muratore, 1
Lecce
73100
Italy

Sponsor information

Vito Fazzi Hospital (Italy)
Hospital/treatment centre

Piazza F. Muratore, 1
Lecce
73100
Italy

ROR logo "ROR" https://ror.org/04fvmv716

Funders

Funder type

Hospital/treatment centre

Vito Fazzi Hospital (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/10/2016 10/05/2021 Yes No

Editorial Notes

10/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.