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
  Purpose

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.


Condition Intervention
Pregnancy
Hypothyroidism
Drug: Anticipatory dose increase of levothyroxine
Drug: levothyroxine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • proportion of patients in each treatment arm euthyroid through gestation [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55
Study Start Date: July 2005
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 tablet increase
Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
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
Active Comparator: 3 tablet increase
Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
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 by 3 extra tablets of their current dose per week.
Other Names:
  • Levoxyl,
  • Synthroid,
  • Unithroid

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230802

Contacts
Contact: Rachael Fawcett, MD 617-732-5208 rfawcett@partners.org
Contact: Erik Alexander 6175255150 ekalexander@rcn.com

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Erik Alexander, MD    617-732-4148      
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard University
Investigators
Principal Investigator: Erik Alexander, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Erik K. Alexander MD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00230802     History of Changes
Other Study ID Numbers: DK44128 (completed)
Study First Received: September 29, 2005
Last Updated: February 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
pregnancy
hypothyroidism
levothyroxine

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014