Thyroid Hormone Dose Adjustment in Pregnancy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00230802
Study type	Interventional
Source	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact	Rachael Fawcett, MD
Phone	617-732-5208
Email	rfawcett@partners.org
Status	Recruiting
Phase	N/A
Start date	July 2005
Completion date	July 2010

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