Thyroid Hormone Dose Adjustment in Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2005 |
| End Date: | July 2010 |
| Contact: | Rachael Fawcett, MD |
| Email: | rfawcett@partners.org |
| Phone: | 617-732-5208 |
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.
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
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
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
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