| September 29, 2005 |
| July 7, 2009 |
| July 2005 |
| July 2010 (final data collection date for primary outcome measure) |
| proportion of patients in each treatment arm euthyroid through gestation [ Time Frame: 9 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00230802 on ClinicalTrials.gov Archive Site |
- the proportion of patients in each arm who required, and the gestation week at which, levothyroxine dose adjustments (either increased or decreased) occurred to maintain a euthyroid state [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- Determination of the necessary frequency of serum evaluation of TSH during the first half of gestation. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Thyroid Hormone Dose Adjustment in Pregnancy |
| Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism. |
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 |
| |
| Interventional |
| Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
|
|
- Drug: Anticipatory dose increase of levothyroxine
- Drug: levothyroxine
|
- Active Comparator: Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
- Active Comparator: Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
|
| |
| |
| Recruiting |
| 55 |
| July 2010 |
| July 2010 (final data collection date for primary outcome measure) |
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
|
| Female |
|
| No |
|
|
| United States |
| |
| NCT00230802 |
| Erik K. Alexander MD, Brigham & Women's Hospital |
| DK44128 |
| Brigham and Women's Hospital |
| Harvard University |
| Principal Investigator: |
Erik Alexander, MD |
Brigham and Women's Hospital |
|
|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| July 2009 |
