NCT00230802

Thyroid Hormone Dose Adjustment in Pregnancy

Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Pregnancy
• Hypothyroidism

Interventions

Type	Name	Description
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
DRUG	levothyroxine	patients will increase levothyroxine by 3 extra tablets of their current dose per week.

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2005-10-03
• Last updated: 2016-12-23
• Results posted: 2016-12-23

Locations

1 site across 1 country: United States