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Thyroid Hormone Dose Adjustment in Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Erik K. Alexander, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00230802
First received: September 29, 2005
Last updated: October 31, 2016
Last verified: October 2016
  Purpose
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 Intervention
Pregnancy
Hypothyroidism
Drug: Anticipatory dose increase of levothyroxine
Drug: levothyroxine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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:
  • the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State [ Time Frame: 9 months ]
  • Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. [ Time Frame: 9 months ]

Enrollment: 48
Study Start Date: July 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
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)
Study First Received: September 29, 2005
Results First Received: May 29, 2012
Last Updated: October 31, 2016

Keywords provided by 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

ClinicalTrials.gov processed this record on March 29, 2017