Thyroid Hormone Dose Adjustment in Pregnancy

Study Overview
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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

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

Conditions
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Pregnancy, Hypothyroidism

Intervention / Treatment
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* Drug: Anticipatory dose increase of levothyroxine
* Drug: levothyroxine
* Drug: levothyroxine


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 tablet increase<br>Patients will increase their current levothyroxine dose by 2 extra tablets per week ( 29% increase) | Drug: Anticipatory dose increase of levothyroxine<br>* as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.<br>* Other names: Unithroid;Drug: levothyroxine<br>* patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week<br>* Other names: unithroid;|
| Active Comparator: 3 tablet increase<br>Patients will increase their levothyroxine dosage by 3 extra tablets per week ( 43%). | Drug: Anticipatory dose increase of levothyroxine<br>* as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.<br>* Other names: Unithroid;Drug: levothyroxine<br>* patients will increase levothyroxine by 3 extra tablets of their current dose per week.<br>* Other names: Unithroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation | The proportion of patients in each treatment arm euthyroid through gestation | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State |  | 9 months | 
| Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy. |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, hypothyroidism, levothyroxine