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Sponsors and Collaborators: |
Brigham and Women's Hospital Harvard University |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00230802 |
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 |
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Pregnancy Hypothyroidism |
Drug: Anticipatory dose increase of levothyroxine Drug: levothyroxine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism. |
Estimated Enrollment: | 55 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2 tablet increase: Active Comparator
Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
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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.
Drug: levothyroxine
patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
|
3 tablet increase: Active Comparator
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.
Drug: levothyroxine
patients will increase levothyroxine by 3 extra tablets of their current dose per week.
|
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
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rachael Fawcett, MD | 617-732-5208 | rfawcett@partners.org |
Contact: Erik Alexander | 6175255150 | ekalexander@rcn.com |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
boston, Massachusetts, United States, 02115 | |
Contact: Erik Alexander, MD 617-732-4148 |
Principal Investigator: | Erik Alexander, MD | Brigham and Women's Hospital |
Responsible Party: | Brigham & Women's Hospital ( Erik K. Alexander MD ) |
Study ID Numbers: | DK44128 |
Study First Received: | September 29, 2005 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00230802 History of Changes |
Health Authority: | United States: Institutional Review Board |
pregnancy hypothyroidism levothyroxine |
Endocrine System Diseases Hypothyroidism Endocrinopathy Hormones Thyroid Diseases |
Endocrine System Diseases Hypothyroidism Thyroid Diseases |