Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/17/2018 |
| Start Date: | August 2011 |
| End Date: | February 2018 |
Randomized, Prospective Trial Comparing the Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
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.
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.
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.
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