Thyroid Hormone Dose Adjustment in Pregnancy - Full Text View

Sponsor:	Brigham and Women's Hospital
Collaborator:	Harvard University
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00230802

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:

MedlinePlus related topics: Thyroid Diseases

Drug Information available for: Thyroxine Levothyroxine Sodium Levothroid Thyroid hormones Thyroid

U.S. FDA Resources

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

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

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
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012