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Thyroid Hormone Dose Adjustment in Pregnancy

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ClinicalTrials.gov Identifier: NCT00230802
Recruitment Status : Completed
First Posted : October 3, 2005
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Erik K. Alexander, Brigham and Women's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Hypothyroidism Drug: Anticipatory dose increase of levothyroxine Drug: levothyroxine Not Applicable

Detailed Description:
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.
Study Start Date : July 2005
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2 tablet increase
Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
 Drug: Anticipatory dose increase of levothyroxine
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

Drug: levothyroxine
patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
Other Names:
  • levoxyl,
  • synthroid
  • unithroid
Active Comparator: 3 tablet increase
Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
 Drug: Anticipatory dose increase of levothyroxine
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

Drug: levothyroxine
patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Other Names:
  • Levoxyl,
  • Synthroid,
  • Unithroid


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230802


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Investigators
Principal Investigator: Erik Alexander, MD Brigham and Women's Hospital
More Information
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Publications of Results:

Responsible Party: Erik K. Alexander, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00230802     History of Changes
Other Study ID Numbers: DK44128 (completed)
First Posted: October 3, 2005    Key Record Dates
Results First Posted: December 23, 2016
Last Update Posted: December 23, 2016
Last Verified: October 2016

Keywords provided by Erik K. Alexander, Brigham and Women's Hospital:
pregnancy
hypothyroidism
levothyroxine

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs