Clinical trial NCT03115515: Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
Official title: Randomized, Prospective Trial Comparing the Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Thyroid
Keywords: Thyroid Stimulating Hormone
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: % of TSH values within trimester-specific goal range per patient from study enrollment to delivery
timeFrame: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Secondary outcomes:
measure: Mean number of LT4 dose adjustment
timeFrame: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
measure: Mean number of LT4 dose adjustments by hypothyroidism etiology
timeFrame: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
measure: % of TSH values at goal according to anti-thyroid antibody status
timeFrame: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
Study officials:
References:
citation: Sullivan SD, Downs E, Popoveniuc G, Zeymo A, Jonklaas J, Burman KD. Randomized Trial Comparing Two Algorithms for Levothyroxine Dose Adjustment in Pregnant Women With Primary Hypothyroidism. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3499-3507. doi: 10.1210/jc.2017-01086.