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

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115515
• Other study ID #: 2011-235
• Status: Completed
• Phase: N/A
• First received: April 7, 2017
• Last updated: March 27, 2018
• Start date: August 2011
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism
• Pregnancy Related
• Thyroid

Intervention

Drug:
• levothyroxine
To compare two different methods of adjusting thyroid hormone replacement during pregnancy to maintain TSH within the normal reference range for pregnancy.

Locations

Country	Name	City	State
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of TSH values within trimester-specific goal range per patient from study enrollment to delivery	% of TSH values within trimester-specific goal range according to study group	TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Secondary	Mean number of LT4 dose adjustment	Mean number of LT4 dose adjustments needed per patient in each group	Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Secondary	Mean number of LT4 dose adjustments by hypothyroidism etiology	Mean number of LT4 dose adjustments needed according to etiology of hypothyroidism in each group	Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery
Secondary	% of TSH values at goal according to anti-thyroid antibody status	TSH values within trimester specific goal range 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