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Thyroid Hormone Dose Adjustment in Pregnancy

NCT ID: NCT00230802

Last Updated: 2016-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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

Conditions

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Pregnancy Hypothyroidism

Keywords

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pregnancy hypothyroidism levothyroxine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2 tablet increase

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

Group Type ACTIVE_COMPARATOR

Anticipatory dose increase of levothyroxine

Intervention Type DRUG

as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.

levothyroxine

Intervention Type DRUG

patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week

3 tablet increase

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

Group Type ACTIVE_COMPARATOR

Anticipatory dose increase of levothyroxine

Intervention Type DRUG

as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.

levothyroxine

Intervention Type DRUG

patients will increase levothyroxine by 3 extra tablets of their current dose per week.

Interventions

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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.

Intervention Type DRUG

levothyroxine

patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week

Intervention Type DRUG

levothyroxine

patients will increase levothyroxine by 3 extra tablets of their current dose per week.

Intervention Type DRUG

Other Intervention Names

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Levoxyl, Synthroid, Unithroid levoxyl, synthroid unithroid Levoxyl, Synthroid, Unithroid

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erik K. Alexander

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20463094 (View on PubMed)

Other Identifiers

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DK44128 (completed)

Identifier Type: -

Identifier Source: org_study_id