Thyroid autoimmunity and history of miscarriage or infertility.
Conditions
Interventions
Trade Name: levothyroxine sodium B.P
Product Name: Levothyroxine sodium
Pharmaceutical Form: Capsule
INN or Proposed INN: Levothyroxine sodium
CAS Number: 51-48-9
Concentration unit: µg microgram(s)
C
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women trying to conceive 2. History of one or more miscarriage(s)or primary/secondary 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 Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Current or past treatment for thyroid disease. 2. Contraindication to levothyroxine treatment. -Thyrotoxicosis. Hypersensitivity to any components tablets. 3. Women taking amiodarone or lithium therapy. 3. Participants in any other blinded, placebo controlled trials on Investigational Medicinal Products in pregnancy. 4. Participants with previous or current cardiac disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that in women with normal thyroid function but with thyroid peroxidase antibodies (TPO), levothyroxine (50mcg, oral, once daily), started pre-conceptually and continued to the end of pregnancy, compared with placebo, increases the proportion of women who attain a live birth beyond 34 completed weeks of gestation by at least 10%.;Secondary Objective: 1. To test the hypothesis that levothyroxine improves secondary outcomes such as on-going pregnancy at 11-13 weeks, gestation at delivery and survival at 28 days of neonatal life. 2. To explore subgroup effects of levothyroxine in prognostic subgroups (maternal age, number of previous miscarriages, women undergoing infertility treatment and initial serum TSH concentration). 3. To test the hypothesis that levothyroxine, compared with placebo, does not incur substantial adverse effects to the mother or the neonate.;Primary end point(s): Live births beyond 34 completed weeks of gestation, as a proportion of all women randomised. This proportion will be calculated with the denominator of all women randomised, and the numerator of women who conceive within 1 year of randomisation and go on to give live birth beyond 34 weeks gestation. Women who fail to conceive within a year, or who become pregnant but either miscarry, give birth before 34 weeks or experience a still birth will thus be included in the denominator but not the numerator.;Timepoint(s) of evaluation of this end point: When Pregnancy has ended for women who have concieved. For women who have not concieved, 12 months after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To test the hypothesis that levothyroxine improves secondary outcomes such as on-going pregnancy at 11-13 weeks, gestation at delivery and survival at 28 days of neonatal life. 2. To explore subgroup effects of levothyroxine in prognostic subgroups (maternal age, number of previous miscarriages, women undergoing infertility treatment and initial serum TSH concentration). 3. To test the hypothesis that levothyroxine, compared with placebo, does not incur substantial adverse effects to the mother or the neonate.;Timepoint(s) of evaluation of this end point: 1.11-13 week ultrasound scan, 28 days after birth 2.Thyroid function tests @ 3 and 6 months pre pregnancy, 6-8 wks, 16-18wks and 28 wks in pregnancy and when pregnancy has ended. 3. 28 days after birth | — |
Countries
United Kingdom
Outcome results
None listed