Thyroid Hormone Dose Adjustment in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Harvard University
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00230802
First received: September 29, 2005
Last updated: February 9, 2011
Last verified: February 2011

September 29, 2005
February 9, 2011
July 2005
July 2010   (final data collection date for primary outcome measure)
proportion of patients in each treatment arm euthyroid through gestation [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00230802 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Determination of the necessary frequency of serum evaluation of TSH during the first half of gestation. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Thyroid Hormone Dose Adjustment in Pregnancy
Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy
  • Hypothyroidism
  • 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.
    Other Names:
    • Levoxyl,
    • Synthroid,
    • Unithroid
  • Drug: levothyroxine
    patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
    Other Names:
    • levoxyl,
    • synthyroid,
    • unithroid
  • Drug: levothyroxine
    patients will increase levothyroxine by 3 extra tablets of their current dose per week.
    Other Names:
    • Levoxyl,
    • Synthroid,
    • Unithroid
  • Active Comparator: 2 tablet increase
    Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
    Interventions:
    • Drug: Anticipatory dose increase of levothyroxine
    • Drug: levothyroxine
  • Active Comparator: 3 tablet increase
    Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
    Interventions:
    • Drug: Anticipatory dose increase of levothyroxine
    • Drug: levothyroxine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Rachael Fawcett, MD 617-732-5208 rfawcett@partners.org
Contact: Erik Alexander 6175255150 ekalexander@rcn.com
United States
 
NCT00230802
DK44128 (completed)
No
Erik K. Alexander MD, Brigham & Women's Hospital
Brigham and Women's Hospital
Harvard University
Principal Investigator: Erik Alexander, MD Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP