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Thyroid Hormone Dose Adjustment in Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Harvard Medical School
Information provided by (Responsible Party):
Erik K. Alexander, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00230802
First received: September 29, 2005
Last updated: October 31, 2016
Last verified: October 2016
Results First Received: May 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pregnancy
Hypothyroidism
Interventions: Drug: Anticipatory dose increase of levothyroxine
Drug: levothyroxine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
2 Tablet Increase Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
3 Tablet Increase Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).

Participant Flow:   Overall Study
    2 Tablet Increase   3 Tablet Increase
STARTED   25   23 
COMPLETED   25   23 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
2 Tablet Increase Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
3 Tablet Increase Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
Total Total of all reporting groups

Baseline Measures
   2 Tablet Increase   3 Tablet Increase   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   23   48 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      25 100.0%      23 100.0%      48 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29  (3)   28  (5)   29  (5) 
Gender 
[Units: Participants]
Count of Participants
     
Female      25 100.0%      23 100.0%      48 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   25   23   48 


  Outcome Measures
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1.  Primary:   Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation   [ Time Frame: 9 months ]

2.  Secondary:   the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State   [ Time Frame: 9 months ]

3.  Secondary:   Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.   [ Time Frame: 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Erik Alexander, MD
Organization: Brigham & Women's Hospital
phone: 6177325666
e-mail: ekalexander@partners.org


Publications of Results:

Responsible Party: Erik K. Alexander, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00230802     History of Changes
Other Study ID Numbers: DK44128 (completed)
Study First Received: September 29, 2005
Results First Received: May 29, 2012
Last Updated: October 31, 2016