Thyroid Hormone Dose Adjustment in Pregnancy
Recruitment status was Recruiting
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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. |
- proportion of patients in each treatment arm euthyroid through gestation [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- 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:
Drug: levothyroxine
patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
Other Names:
|
|
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:
Drug: levothyroxine
patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Other Names:
|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00230802
| Contact: Rachael Fawcett, MD | 617-732-5208 | rfawcett@partners.org | |
| Contact: Erik Alexander | 6175255150 | ekalexander@rcn.com |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Erik Alexander, MD 617-732-4148 | |
| 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 Endocrine System Diseases Thyroid Diseases |
ClinicalTrials.gov processed this record on February 25, 2015