Thyroid Hormone Dose Adjustment in Pregnancy
This study has been completed.
Sponsor:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00230802
First Posted: October 3, 2005
Last Update Posted: December 23, 2016
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Erik K. Alexander, Brigham and Women's Hospital
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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: None (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
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| 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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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) |
| First Submitted: | September 29, 2005 |
| First Posted: | October 3, 2005 |
| Results First Submitted: | May 29, 2012 |
| Results First Posted: | December 23, 2016 |
| Last Update Posted: | December 23, 2016 |
| Last Verified: | October 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 |