Clinical trial NCT00230802: Thyroid Hormone Dose Adjustment in Pregnancy
Official title: Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Hypothyroidism
Keywords: pregnancy
hypothyroidism
levothyroxine
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2005-10-03
Enrollment: 48
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation
timeFrame: 9 months
Secondary outcomes:
measure: the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State
timeFrame: 9 months
measure: Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.
timeFrame: 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Erik Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yassa L, Marqusee E, Fawcett R, Alexander EK. Thyroid hormone early adjustment in pregnancy (the THERAPY) trial. J Clin Endocrinol Metab. 2010 Jul;95(7):3234-41. doi: 10.1210/jc.2010-0013. Epub 2010 May 12.