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Completed

NCT Number: NCT03115515

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.

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Key information

Conditions

Pregnancy Related Endocrine System Diseases Thyroid Thyroid Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levothyroxine

Drug

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

Other names: Synthroid, Levoxyl

Primary outcomes

  1. % of TSH values within trimester-specific goal range per patient from study enrollment to delivery

    Time frame: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery

    % of TSH values within trimester-specific goal range according to study group

Secondary outcomes

  1. Mean number of LT4 dose adjustment

    Time frame: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery

    Mean number of LT4 dose adjustments needed per patient in each group

  2. Mean number of LT4 dose adjustments by hypothyroidism etiology

    Time frame: Dose adjustments will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery

    Mean number of LT4 dose adjustments needed according to etiology of hypothyroidism in each group

  3. % of TSH values at goal according to anti-thyroid antibody status

    Time frame: TSH will be assessed every 2 weeks from enrollment to 28 weeks gestation and then every 4 weeks from 29 weeks to delivery

    TSH values within trimester specific goal range according to anti-thyroid antibody status

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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