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
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
Scientific
Piazza F. Muratore, 1
Lecce
73100
Italy
| robnegro@tiscali.it |
Study information
| Study design | Interventional randomised single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Miscarriage and Levothyroxine treatment in euthyroid spontaneously pregnant women with thyroid Antibodies: an interventional randomised single-centre trial |
| Study acronym | MiLAb |
| Study objectives | 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(s) | Institutional Review Board, 11/11/2010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levothyroxine |
| Primary outcome measure | 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 study start date | 01/01/2011 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 175 patients for each arm (350 in total) |
| Total final enrolment | 590 |
| Key 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 |
| Key exclusion criteria | 1. Current or past treatment for thyroid disease 2. Contraindication to levothyroxine treatment 3. Drugs interfering with thyroid function |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
73100
Italy
Sponsor information
Hospital/treatment centre
Piazza F. Muratore, 1
Lecce
73100
Italy
"ROR" |
https://ror.org/04fvmv716 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
