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Thyroid Hormone Dose Adjustment in Pregnancy

Primary Purpose

Pregnancy, Hypothyroidism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anticipatory dose increase of levothyroxine
levothyroxine
levothyroxine
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring pregnancy, hypothyroidism, levothyroxine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2 tablet increase

3 tablet increase

Arm Description

Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)

Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).

Outcomes

Primary Outcome Measures

Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation
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
Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.

Full Information

First Posted
September 29, 2005
Last Updated
October 31, 2016
Sponsor
Brigham and Women's Hospital
Collaborators
Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT00230802
Brief Title
Thyroid Hormone Dose Adjustment in Pregnancy
Official Title
Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Harvard Medical School (HMS and HSDM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Hypothyroidism
Keywords
pregnancy, hypothyroidism, levothyroxine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 tablet increase
Arm Type
Active Comparator
Arm Description
Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
Arm Title
3 tablet increase
Arm Type
Active Comparator
Arm Description
Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
Intervention Type
Drug
Intervention Name(s)
Anticipatory dose increase of levothyroxine
Other Intervention Name(s)
Levoxyl,, Synthroid,, Unithroid
Intervention Description
as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.
Intervention Type
Drug
Intervention Name(s)
levothyroxine
Other Intervention Name(s)
levoxyl,, synthroid, unithroid
Intervention Description
patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week
Intervention Type
Drug
Intervention Name(s)
levothyroxine
Other Intervention Name(s)
Levoxyl,, Synthroid,, Unithroid
Intervention Description
patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Primary Outcome Measure Information:
Title
Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation
Description
The proportion of patients in each treatment arm euthyroid through gestation
Time Frame
9 months
Secondary Outcome Measure Information:
Title
the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State
Time Frame
9 months
Title
Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.
Time Frame
9 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Alexander, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20463094
Citation
Yassa L, Marqusee E, Fawcett R, Alexander EK. Thyroid hormone early adjustment in pregnancy (the THERAPY) trial. J Clin Endocrinol Metab. 2010 Jul;95(7):3234-41. doi: 10.1210/jc.2010-0013. Epub 2010 May 12.
Results Reference
result

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Thyroid Hormone Dose Adjustment in Pregnancy

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