Thyroid Hormone Dose Adjustment in Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00230802
• Other study ID #: DK44128 (completed)
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2005
• Last updated: February 9, 2011
• Start date: July 2005
• Est. completion date: July 2010

Study information

• Verified date: February 2011
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: Rachael Fawcett, MD
• Phone: 617-732-5208
• Email: rfawcett[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypothyroidism
• Pregnancy

Intervention

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.
• levothyroxine
patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
• levothyroxine
patients will increase levothyroxine by 3 extra tablets of their current dose per week.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients in each treatment arm euthyroid through gestation		9 months	Yes
Secondary	the proportion of patients in each arm who required, and the gestation week at which, levothyroxine dose adjustments (either increased or decreased) occurred to maintain a euthyroid state		9 months	Yes
Secondary	Determination of the necessary frequency of serum evaluation of TSH during the first half of gestation.		9 months	Yes