At a glance
ClinicalIndex Comparison Record- ✓Women with prior diagnosis of hypothyroidism currently on levothyroxine therapy
- ✓Less than 8 weeks pregnant at enrollment
- ✕Cardiac disease
- ✕Renal failure
- ✕Not biochemically euthyroid within 6 months prior to pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.
In Brief
A clinical study evaluating Anticipatory dose increase of levothyroxine and levothyroxine for Pregnancy and Hypothyroidism. Completed, enrolled 48 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
patients will increase levothyroxine by 3 extra tablets of their current dose per week.