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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 tablet increase | Active Comparator | Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase) |
|
| 3 tablet increase | Active Comparator | Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation | The proportion of patients in each treatment arm euthyroid through gestation | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State | 9 months | |
| Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Alexander, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20463094 | Result | Yassa L, Marqusee E, Fawcett R, Alexander EK. Thyroid hormone early adjustment in pregnancy (the THERAPY) trial. J Clin Endocrinol Metab. 2010 Jul;95(7):3234-41. doi: 10.1210/jc.2010-0013. Epub 2010 May 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 Tablet Increase | Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase) |
| FG001 | 3 Tablet Increase | Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 Tablet Increase | Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase) |
| BG001 | 3 Tablet Increase | Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation | The proportion of patients in each treatment arm euthyroid through gestation | proportion of patients in each treatment arm euthyroid through gestation | Posted | Number | participants | 9 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 Tablet Increase | Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erik Alexander, MD | Brigham & Women's Hospital | 6177325666 | ekalexander@partners.org |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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|
| levothyroxine | Drug | patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week |
|
|
| levothyroxine | Drug | patients will increase levothyroxine by 3 extra tablets of their current dose per week. |
|
|
| 9 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State | Posted | Number | participants | 9 months |
|
|
|
| Secondary | Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. | Posted | Number | participants | 9 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 3 Tablet Increase | Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%). | 0 | 23 | 0 | 23 |
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| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |