Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy

Completed · Not applicable

Conditions studied: Pregnancy Related, Thyroid

In brief

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.

Key facts

Study ID

NCT03115515

Run by

Medstar Health Research Institute

People needed

60

Starts

2011-08-01

Expected to finish

2018-02-01

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female between ages of 18-45 who takes thyroid hormone replacement medicine AND pregnant or plan to become pregnant in the near future.

You may not qualify if…

• 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.

Where it is running

• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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