Thyroid Hormone Dose Adjustment in Pregnancy

October 31, 2016 updated by: Erik K. Alexander, Brigham and Women's Hospital

Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • synthroid
  • levoxyl,
  • unithroid
Drug: levothyroxine
patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Other Names:
  • Levoxyl,
  • Synthroid,
  • 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 dosage by 2 extra tablets of their current dose per week
Other Names:
  • synthroid
  • levoxyl,
  • unithroid
Drug: levothyroxine
patients will increase levothyroxine by 3 extra tablets of their current dose per week.
Other Names:
  • Levoxyl,
  • Synthroid,
  • Unithroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State
Time Frame: 9 months
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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Harvard Medical School (HMS and HSDM)

Investigators

  • Principal Investigator: Erik Alexander, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (ESTIMATE)

October 3, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK44128 (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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