Thyroid Hormone Dose Adjustment in Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy; Hypothyroidism
• Interventions: Drug: Anticipatory dose increase of levothyroxine; Drug: levothyroxine

• Registration Number: NCT00230802
• Lead Sponsor: Brigham and Women's Hospital

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

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-29
• Study First Submitted QC: 2005-09-29
• Study First Posted: 2005-10-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2012-05-29
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Results First Posted: 2016-12-23
• Last Update Posted: 2016-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy
• less than 8 weeks pregnant

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Exclusion Criteria

• cardiac disease, renal failure
• not euthyroid biochemically within 6 months pre-pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 tablet increase	levothyroxine	Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)
3 tablet increase	levothyroxine	Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).
2 tablet increase	Anticipatory dose increase of levothyroxine	Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase)
3 tablet increase	Anticipatory dose increase of levothyroxine	Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).

Primary Outcome Measures

Name	Time	Method
Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation	9 months	The proportion of patients in each treatment arm euthyroid through gestation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States