Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2014
Date assigned
21/05/2014
Last edited
21/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roberto Negro

ORCID ID

Contact details

Piazza F. Muratore
1
Lecce
73100
Italy
robnegro@tiscali.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Miscarriage and Levothyroxine treatment in euthyroid spontaneously pregnant women with thyroid Antibodies: an interventional randomised single-centre trial

Acronym

MiLAb

Study hypothesis

We hypothesized that treatment with Levothyroxine in euthyroid spontaneously pregnant patients within the first trimester of pregnancy may reduce the rate of miscarriage.

Ethics approval

Institutional Review Board, 11/11/2010

Study design

Interventional randomised single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic autoimmune thyroiditis in pregnancy

Intervention

The 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 type

Drug

Phase

Not Applicable

Drug names

Levothyroxine

Primary outcome measures

Number of miscarriages, defined as fetal death within 20 weeks of gestation. Time point is 20 weeks of gestation

Secondary outcome measures

Number of preterm births, defined as birth before 37 complete weeks of gestation. Time point is end of pregnancy

Overall trial start date

01/01/2011

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

175 patients for each arm (350 in total)

Participant exclusion criteria

1. Current or past treatment for thyroid disease
2. Contraindication to levothyroxine treatment
3. Drugs interfering with thyroid function

Recruitment start date

01/01/2011

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Piazza F. Muratore, 1
Lecce
73100
Italy

Sponsor information

Organisation

Vito Fazzi Hospital (Italy)

Sponsor details

Piazza F. Muratore
1
Lecce
73100
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Vito Fazzi Hospital (Italy)

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