Thyroid Hormone Dose Adjustment in Pregnancy

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Harvard Medical School; Harvard Medical School (HMS and HSDM); Harvard University
• Treatments: Hormones

Criteria

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