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Thyroid Hormone Dose Adjustment in Pregnancy
This study has been completed.
Sponsor:
Brigham and Women's Hospital
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Erik K. Alexander, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00230802
First received: September 29, 2005
Last updated: October 31, 2016
Last verified: October 2016
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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 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 Erik K. Alexander, Brigham and Women's Hospital:
Primary Outcome Measures:
- Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation [ Time Frame: 9 months ]The proportion of patients in each treatment arm euthyroid through gestation
Secondary Outcome Measures:
- the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State [ Time Frame: 9 months ]
- Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. [ Time Frame: 9 months ]
| Enrollment: | 48 |
| Study Start Date: | July 2005 |
| Study Completion Date: | July 2010 |
| 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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00230802
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230802
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Medical School
Investigators
| Principal Investigator: | Erik Alexander, MD | Brigham and Women's Hospital |
More Information
Publications:
| Responsible Party: | Erik K. Alexander, Associate Professor of Medicine, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00230802 History of Changes |
| Other Study ID Numbers: |
DK44128 (completed) |
| Study First Received: | September 29, 2005 |
| Results First Received: | May 29, 2012 |
| Last Updated: | October 31, 2016 |
Keywords provided by Erik K. Alexander, Brigham and Women's Hospital:
|
pregnancy hypothyroidism levothyroxine |
Additional relevant MeSH terms:
|
Hypothyroidism Thyroid Diseases Endocrine System Diseases |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 22, 2017