Thyroid Hormone Dose Adjustment in Pregnancy

Completed · Not applicable

Conditions studied: Pregnancy, Hypothyroidism

In brief

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.

Key facts

Study ID

NCT00230802

Run by

Brigham and Women's Hospital

People needed

48

Starts

2005-07-01

Expected to finish

2010-07-01

Last updated by the study team

2016-12-23

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy
• less than 8 weeks pregnant

You may not qualify if…

• cardiac disease, renal failure
• not euthyroid biochemically within 6 months pre-pregnancy

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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