Pregnancy Related, Thyroid
Conditions
Keywords
Thyroid Stimulating Hormone
Brief summary
In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly in pregnancy and it is important that blood levels of thyroid hormone remain normal so the fetus, which cannot make its own thyroid hormone has enough for early prenatal development. This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid medication every 2-4 weeks in micrograms per day based on results of blood tests. The investigators will compare thyroid hormone levels throughout pregnancy between the groups of mothers to determine which method is superior in meeting the increased thyroid hormone requirements during pregnancy.
Interventions
DRUGlevothyroxine
To compare two different methods of adjusting thyroid hormone replacement during pregnancy to maintain TSH within the normal reference range for pregnancy.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female between ages of 18-45 who takes thyroid hormone replacement medicine AND pregnant or plan to become pregnant in the near future.
Exclusion criteria
* Males * Younger than 18 or older than 45 years old * More than 10 weeks pregnant at enrollment * Iodine deficient * Pregnant with more than one baby (i.e., twins, triplets, etc.) * NOT taking thyroid hormone medicine before becoming pregnant * Levels of thyroid hormone in blood have been too low or too high in the past 6 months * Treated with radioactive iodine in the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of TSH values within trimester-specific goal range per patient from study enrollment to delivery | TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery | % of TSH values within trimester-specific goal range according to study group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of LT4 dose adjustment | Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery | Mean number of LT4 dose adjustments needed per patient in each group |
| Mean number of LT4 dose adjustments by hypothyroidism etiology | Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery | Mean number of LT4 dose adjustments needed according to etiology of hypothyroidism in each group |
| % of TSH values at goal according to anti-thyroid antibody status | TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery | TSH values within trimester specific goal range according to anti-thyroid antibody status |
Countries
United States
Outcome results
None listed