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OpenTrials
Completed

NCT Number: NCT00230802

Thyroid Hormone Dose Adjustment in Pregnancy

Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.

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Key information

Conditions

Pregnancy Endocrine System Diseases Hypothyroidism Thyroid Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy
  • less than 8 weeks pregnant

Exclusion criteria

  • cardiac disease, renal failure
  • not euthyroid biochemically within 6 months pre-pregnancy

Treatment and study plan

Anticipatory dose increase of levothyroxine

Drug

as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.

Other names: Levoxyl,, Synthroid,, Unithroid

Levothyroxine

Drug

patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week

Other names: levoxyl,, synthroid, unithroid

Primary outcomes

  1. Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation

    Time frame: 9 months

    The proportion of patients in each treatment arm euthyroid through gestation

Secondary outcomes

  1. the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State

    Time frame: 9 months

  2. Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)

Registry information

Official study title

Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 3, 2005
Registry last updated
Dec 23, 2016

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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