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

NCT ID: NCT03115515

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2018-02-28

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.

Conditions

Pregnancy Related; Thyroid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjustment in number of doses of thyroid hormone per week

Patients in this group will increase pre-pregnancy thyroid hormone dose by 2 doses/week (extra dose on Wednesday and Saturday). Further dose adjustment are made every 2-4 weeks based on serum TSH, as shown below:

• TSH>10mIU/L, increase by 3 doses/week
• TSH 5.0-9.9mIU/L, increase by 2 doses/week
• TSH 2.0-4.9mIU/L, increase by 1 dose/week
• TSH 0.4-1.9mIU/L, no change
• TSH<0.4mIU/L, decrease by 1 dose/week
• TSH<0.1mIU/L, decrease by 2 doses/week
• Thyroid hormone dose will NOT be decreased due to TSH<0.4mIU/L during the 1st trimester unless patient also has elevated circulating T4 and/or T3 levels, indicate of true hyperthyroidism.

Group Type: EXPERIMENTAL

levothyroxine

Intervention Type: DRUG

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

Adjustment in micrograms per day of thyroid hormone

Patients in this group adjust thyroid hormone dose based on Visit 1 TSH and pre-pregnancy thyroid hormone dose. Further dose adjustments are made every 2-4 weeks based on serum TSH, as shown below:

• TSH>10mIU/L, increase dose by 50mcg/day if dose <125mcg/day or increase by 75mcg/day if dose >125mcg
• TSH 5.0-9.9mIU/L, increase dose by 25mcg/day if dose <125mcg/day or increase by 50mcg/day if dose >125mcg
• TSH 2.0-4.9mIU/L, increase dose by 12.5mcg/day if dose <125mcg/day or increase by 25mcg/day if dose >125mcg
• TSH 0.4-1.9mIU/L, no change
• TSH<0.4mIU/L, decrease dose by 12.5mcg/day if dose <125mcg/day or decrease by 25mcg/day if dose >125mcg/day
• TSH<0.1mIU/L, decrease dose by 25mcg/day if dose <125mcg/day or decrease by 50mcg/day if dose >125mcg/day
• Thyroid hormone dose will NOT be decreased due to TSH<0.4mIU/L during the 1st trimester unless patient also has elevated circulating T4 and/or T3 levels, indicate of true hyperthyroidism.

Group Type: EXPERIMENTAL

levothyroxine

Intervention Type: DRUG

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

Interventions

levothyroxine

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

Intervention Type: DRUG

Other Intervention Names

Synthroid; Levoxyl

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Shannon Sullivan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28911144 (View on PubMed)

Other Identifiers

2011-235

Identifier Type: -

Identifier Source: org_study_id