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
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